3,681 Regulatory Specialists jobs in the United States

Job Description

Description:
Job Duties and Qualifications

Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.

Essential Functions
• Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
• Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
• Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
• Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
• May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;
• May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;
• May prepare and deliver regulatory training to IQVIA small groups or individuals;
• Performs other tasks or assignments, as delegated by Regulatory management;

Qualifications
• Bachelor's Degree Degree in Lifescience or related discipline Req Or
• Master's Degree Degree in Lifescience or related discipline Req
• At least 3-4 years relevant experience
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Possesses a specific regulatory or technical expertise;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
• Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
• Ability to adapt quickly to a rapidly changing environment;

Pay Rate Range: $30-38/hr depending on experience

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

We are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are passionate about regulatory affairs and looking for an opportunity to grow within a dynamic company, we encourage you to apply.

Responsibilities:

• Prepare, review, and submit regulatory documents to ensure compliance with FDA and other regulatory authorities.
• Maintain up-to-date knowledge of regulations, guidelines, and standards relevant to the pharmaceutical industry.
• Assist in the preparation of regulatory submissions including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and amendments.
• Coordinate with cross-functional teams to gather necessary information for regulatory submissions.
• Ensure timely and accurate communication with regulatory authorities.
• Monitor and track the progress of submissions and respond to any inquiries from regulatory bodies.
• Assist in the development and implementation of regulatory strategies to support product approvals and lifecycle management.
• Maintain accurate and organized regulatory files and records.

Requirements:

• Bachelor's degree in a related field such as biology, chemistry, or pharmaceutical sciences.
• Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred.
• Strong understanding of FDA regulations and guidelines.
• Excellent organizational and time management skills.
• Strong attention to detail and ability to handle multiple projects simultaneously.
• Effective communication skills, both written and verbal.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and as part of a team.

Regulatory Affairs Specialist page is loaded

Regulatory Affairs Specialist Apply locations USA, Georgia, Atlanta USA, Texas, Houston time type Full time posted on Posted 3 Days Ago job requisition id R0029951

Job Description:

At Enovis we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence with the goal of transforming medical technology as we know it.

Because thats how we change the lives of patients for the better. And thats how we create better together. Why work at Enovis? See for yourself .

Job Title :

Regulatory Affairs Specialist

Reports To :

Director, Regulatory Affairs | Foot & Ankle

Location:

Atlanta, GA or Houston, TX

Business Unit Description :

Regulatory Affairs

High-Level Position Summary :

We are seeking a skilled and experienced Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will be supporting a wide range of regulatory activities to ensure compliance with global submission requirements, departmental processes, and quality system standards. This role will develop regulatory strategies, complete impact assessments, and prepare submissions including U.S. FDA 510(k)s, EU MDR Technical Documentation and other OUS registrations. The RA Specialist will support the Foot & Ankle Business Unit (F&A BU), contribute to new product development and sustaining projects, and engage with global regulatory authorities including the FDA and EU Notified Body.

Key Responsibilities

The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.

• Provide regulatory expertise and guidance to cross-functional teams for both new product development and sustaining projects.
• Complete regulatory deliverables for assigned projects, including strategy development, impact assessments, and submission preparation through to clearance or approval.
• Prepare global submissions including but not limited to U.S. FDA 510(k) Premarket Notifications, PMA submissions, EU MDR Technical Documentation, and other international product registrations
• Collaborate with cross-functional teams to collect and review technical documentation, ensuring accuracy, regulatory compliance, and timely submissions.
• Communicate and negotiate with global regulatory bodies during submission reviews, audits, and post-market activities.
• Identify risks and develop contingency plans for assigned regulatory projects.
• Interpret and communicate regulatory requirements and guidance to internal teams and stakeholders.
• Maintain regulatory databases, trackers, and documentation in accordance with internal procedures and applicable regulations.
• Support compliance-related activities such as site registrations, audits, and post-market surveillance (e.g., HHEs, MDRs, FAs, CAPAs).
• Apply quality system knowledge to all job functions.
• Perform additional tasks as assigned by the Regulatory Manager.
• Comply with Enovis's Code of Conduct, company policies, procedures, and standards.

Currently, Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

Minimum Basic Qualifications:

• Bachelors degree in a scientific discipline (e.g., biology, microbiology, chemistry, engineering, or medical technology).
• Minimum 5 years of regulatory affairs experience in the medical device industry.
• Proven experience preparing U.S. FDA 510(k) submissions.
• Strong understanding of design and change control processes, regulatory assessments, and quality system requirements under ISO 13485 and FDA QSR.
• Experience working cross-functionally and with regulatory agencies.

Desired Characteristics :

• Experience with international registrations and submissions including EU MDR.
• Knowledge of medical device labeling and associated regulations.
• High attention to detail with a focus on accuracy and completeness.
• Strong written and verbal communication skills.
• Excellent organizational, planning, and time management abilities.
• Analytical and problem-solving mindset.
• Strong interpersonal and team collaboration skills.
• Ability to work independently with minimal supervision.
• Adaptable, proactive, and capable of leading regulatory initiatives.
• Proficient in Microsoft Office, Adobe Acrobat, and Agile PLM systems.

Travel: 10%

Work environment | Physical demands:

Ability to sit and stand for long periods of time.

Work schedule:

Hybrid schedule is available with three days on-site.

Creating better together. Its the Enovis purpose, and its what drives us and empowers us every day on a global scale. We know that the power to create better for our customers, our team members, and our shareholders begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Watch this short on creating the next generation of better together at Enovis:

Better is. | Enovis

We offer a comprehensive benefits package which includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent, and innovation, the Companys extensive range of products, services, and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Companys extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.For more information about Enovis, please visit .

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

About Us

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Companys extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit .

#J-18808-Ljbffr

Reputable Medical Device Company - Looking for Full Time Regulatory Affairs Specialist

This Jobot Job is hosted by: Victoria Casal
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $37.5 - $48 per hour

A bit about us:

** THIS IS AN ONSITE POSITION IN VALENCIA (Occasionally in Burbank) **

Reputable Medical Device company

Why join us?

Competitive Salary
Employer paid Benefits (Medical/ Dental/ Vision)
PTO Package
Health Care and Dependent Care Flex Spending
401K
Profit-sharing program
Flexible work environment

Job Details

Responsibilities:

1. Develop and implement regulatory strategies and plans to ensure timely and successful market introduction of new products and updates to existing products.
2. Prepare and maintain technical files and design dossiers to support CE marking of products, including risk analysis and post-market surveillance reports.
3. Review and approve product labeling, promotional materials, and product changes as per regulatory requirements.
4. Ensure compliance with ISO 9001 and ISO 13485, MDR, EU MDD, MDD, CFR, and other relevant standards.
5. Maintain a robust document management system and ensure its compliance with regulatory requirements.
6. Liaise with regulatory authorities and notified bodies to resolve any issues that may arise during the product approval process.
7. Actively participate in internal and external audits and inspections.
8. Continuously monitor changes in the regulatory landscape and update the internal teams accordingly.

Qualifications:

1. A minimum of a Bachelor's degree in a scientific or technical field, or equivalent.
2. Minimum 4+ years of experience in regulatory affairs in the scientific industry.
3. Strong knowledge of QA, Quality Assurance, Quality Controls, ISO 9001, ISO13485, MDR, EU MDD, MDD, CFR, and Document Management.
4. Excellent written and verbal communication skills.
5. Strong analytical and problem-solving skills.
6. Ability to work collaboratively with cross-functional teams.
7. Strong attention to detail and the ability to manage multiple tasks simultaneously.
8. Proven track record of successful product approvals and audits.
9. Proficiency in using document management systems and other software tools.

You must be able to travel and work in Valencia with occasional visits to the Burbank facility.

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

About Neuralink:

We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.

Team Description:

Join the Quality Team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance.

Job Description and Responsibilities:

As the Regulatory Affairs Specialist at Neuralink, you will be responsible for regulatory affairs activities and interactions with international regulatory bodies during clinical evaluations and/or market introduction, as well as compliance and reporting activities in the post-market phase. Additionally, you will develop regulatory approaches for devices under development, prepare pre-market regulatory submissions, and create post-approval reports. Furthermore, you will be expected to:

• Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing) to ensure product compliance
• Identify regulatory obstacles, anticipate emerging issues, and propose solutions or refinements based on regulatory outcomes
• Evaluate product classification and determine regulatory submission requirements, approval pathways, and compliance options, as well as prepare regulatory filings in line with applicable guidelines
• Develop and implement new regulatory procedures and SOPs, and provide training to stakeholders to ensure organization-wide compliance
• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans or strategize for changes that do not require submissions
• Maintain proficiency in worldwide regulatory requirements and distribute updated information regarding worldwide laws, guidelines, and standards
• Collect, organize, and maintain files on local, regional, and global regulatory intelligence and other related information
• Provide information used to evaluate proposed products for regulatory classification and jurisdiction
• Organize materials from preclinical and clinical studies for review and assist in the review process
• Compile and organize materials for pre-submission reports and communications
• Assist in the preparation of dossiers, pre-submission, and submission packages for regulatory agencies
• Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders

Required Qualifications:

• Bachelor's Degree or higher in an applicable science or engineering discipline
• 2+ years of professional experience in regulatory submissions and technical documentation (e.g., IDE, HDE, PMA, notices, supplements, routine reports
• Excellent communication, collaboration, and organization skills

Preferred Qualifications:

• Experience with significant risk medical device-related regulatory filings
• Experience with robotics, software, and cybersecurity-related regulatory filings
• RAPs or ASQ certification or other scientific/technical training

What We Offer:

Full-time employees are eligible for the following benefits listed below.

• An opportunity to change the world and work with some of the smartest and most talented experts from different fields
• Growth potential; we rapidly advance team members who have an outsized impact
• Excellent medical, dental, and vision insurance through a PPO plan
• Paid holidays
• Commuter benefits
• Meals provided
• Equity (RSUs) *Temporary Employees & Interns excluded
• 401(k) plan *Interns initially excluded until they work 1,000 hours
• Parental leave *Temporary Employees & Interns excluded
• Flexible time off *Temporary Employees & Interns excluded

Job Description:

The Regulatory Affairs Specialist is responsible for assembling CE Technical files and final review of deliverables for MDR regulatory compliance with the goal of achieving notified body approval. This individual will also track marketing clearances/approvals, licenses, and applications for products to support sustainment projects and new product launches.

Job Requirements:

PRIMARY DUTIES & RESPONSIBILITIES:

• Work on ad-hoc projects when required.
• Request Certificate of Foreign Government and Certificates of Free Sale
• Resolve regulatory issues and ensure companywide compliance.
• Reviews regulatory publications to keep apprised of new regulatory developments.
• Performs special projects at the direction of the Regulatory Affairs Management.
• Responsible for assembling an CE technical file.
• Responsible for authoring, and or reviewing CER, SSCP, PSUR, and PMS reports.
• Works in partnership with manufacturing and RA/QA in designing and enhancing quality management systems to facilitate overall regulatory compliance.
• Responsible for authoring department standard operating procedure (SOPs).
• Responsible for FDA/Canadian device/drug establishment registrations and device/drug listings (as required).
• Responsible for assisting in regulatory review of product claims and literature.
• Prepares monthly reports on status of current issues to the Manager of Regulatory Affairs.
• Assists with Customs requests.
• Responsible for global submissions (as required).
• Tracks submissions and maintains electronic and paper regulatory correspondence and approvals (ex: FDA, HC, EU and ROW).
• Provide regulatory support for Health Authority submissions including but not limited to proofreading documentation.
• Organize and maintain files/folders/databases for all business units to support the integrity of RA documentation.
• Management of the RA department purchase credit card (p-card) and monthly reconciliation.
• Coordination and submission of all purchasing requests within the RA department.
• Order documents, subscriptions, articles, standards and other items.
• Provide support and coordination for regulatory shipments (UPS, etc.).
• Coordination of all notarization and authentication (legalization) efforts for business units done per country requirements.
• Work on ad-hoc projects when required.
• Request Certificate of Foreign Government and Certificates of Free Sale
• Resolve regulatory issues and ensure companywide compliance.
• Reviews regulatory publications to keep apprised of new regulatory developments.
• Performs special projects at the direction of the Regulatory Affairs Management.
• Any duties or projects assigned by Manager.

REQUIREMENTS:

• Bachelor's Degree (BA/BS) from four-year college/university
• 2+ years of medical device experience, and/or training in an FDA-regulated industry, or equivalent combination of education and experience; or 1+ years regulatory experience with a master's degree from a college/university.
• Respectful of peers. Open-minded and willing to take an educated risk, fail fast and try again. Challenge the status quo and seek opportunities to set new standards.
• Accountable his/her work, good or bad. Takes initiative to make a positive difference and win with our customers and co-workers.
• Sense of urgency and attention to detail. Must have "can do" attitude and be a team player.
• Proven ability to prioritize assigned projects and manage time effectively to meet all deadlines.
• Ability to understand technical product information
• Must have an above average understanding of the European MDR regulation, and CER, SSCP, PMS, and PSUR reports.
• Must have the ability to assemble a CE technical file.

PREFERRED QUALIFICATIONS :

• Experience with the registrations of orthodontic medical devices in the global market is a plus
• Has built processes and procedures contributing to regulatory strategy
• Effective collaborator with department and cross-functional team members and comfortable working independently with limited direction/supervision
• Demonstrated organizational problem-solving skills, project coordination skills and computer literacy in Microsoft Office suite, databases and electronic document management systems
• Enthusiastic self-starter with excellent verbal, written, and interpersonal skills
• Highly organized, detail-oriented "mindset" and ability to be flexible and multi-task in a dynamically changing environment
• The ability to interpret and provide guidance on regulations from various countries
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
• Ability to write routine reports and correspondence.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is:

• Regularly required to sit.
• Frequently required to walk
• Occasionally required to stand
• Occasionally lift and/or move up to 25 pounds
• Quite to moderate noise level work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

#LI-RJ1

IND123

Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$42,300 - $63,400

Operating Company:
Ormco

Ormco is a global leader and innovator of high-quality orthodontic products and solutions, including brackets and wires. For more than 60 years, our team has partnered with the orthodontic community to help create over 20 million smiles in more than 140 countries. We build trusted relationships. Each one is rooted in respect and understanding. We take that approach when we help orthodontists achieve their clinical and practice management objectives. We take the same approach when we help our team bring their personal best to work each day, ready to make a difference and reach their full potential.

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available at: compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Regulatory Affairs Specialist

Job Type: Regular

Company: Health Research, Inc. (HRI) Roswell Park Division

Department: Clinical Trials Office

Time Type: Full time

Weekly Hours: 40

FTE: 1

Shift: First Shift (United States of America)

Summary: Ensures that Roswell Park IND's/IDE's and other regulatory submission types are in compliance with FDA regulations; keeps current on changes in regulations for drugs, biologics, devices and tobacco products; advises investigators on FDA requirements as they apply to the specific application which includes pre-clinical, pharmacological, toxicology, chemistry, manufacturing and control of investigational agents; interprets and applies FDA regulations to investigational product applications and provides regulatory input, advice, guidance to the investigators; maintains and tracks FDA regulatory submissions electronically.

The pay range for this position is $73,627 - $90,955 annually which includes a comprehensive benefits package. The listed pay range reflects the range of potential compensation for this role. The actual offer may vary based on qualifications, skills, and experience. We are recruiting for multiple candidates on this posting!

Qualifications:

Required Education and Experience Certification Requirement:

• Current certification by the Regulatory Affairs Professionals Society (RAPS) preferred; or ability to secure RAC within three (3) years of employment.
• Education and Experience: Bachelor's degree and the equivalent of four (4) years of full-time research experience, two (2) years which must have been in regulatory affairs, clinical research or a related field involving FDA regulations.
• NOTE: 1. Incumbents must obtain a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) within three (3) years of appointment to this position as a condition of continued employment.
• 2. Required degrees must have been granted by an accredited school, college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices.

Preferred Qualifications:

The preferred candidate will have, Research Certification, Document management experience and Knowledge of FDA regulations.

Equal Employment Opportunity Statement:

Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual's relationship or association with a member of a protected category or any other protected group status as defined by law.

Our Core Values:

RPCIC and HRI are committed to providing an environment where patients, families, employees and community are treated with courtesy and respect. We support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect our core values: Innovation, Integrity, Teamwork, Commitment, Compassion and Respect.

Grant Funding:

This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.

E-Verify Employer:

Health Research Inc. (HRI) Roswell Park Division participates in the E-Verify program.