40 Regulatory Affairs Specialist jobs in the United States

Regulatory Affairs Specialist needs 2+ years experience

Regulatory Affairs Specialist requires:

Bachelors Degree in Chemistry, Biology, Toxicology or related field.

Experience in professional level position in business.

Experience with OSHA/TSCA/RCRA/Export regulations desirable.

Ability to manage multiple projects while effectively communicating status to senior staff.

Excellent written and oral communication skills.

Excellent Computer Skills. SAP experience, preferred

Background in Industrial Chemical Regulatory Affairs

Understands local country adoption such as US (Haz Comm 2012) and Canada (WHMIS 2015).

Regulatory Affairs Specialist duties:

Responsible for classifying new and existing products according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

Pre-Authoring of Safety Data Sheets (SDS) and labels in accordance to Haz Comm 2012 and WHMIS 2015.

Supporting projects related to management of change and the regulatory process.

Answer Simple Customer Queries

Leading and well renowned manufacturer of glass, electronic displays and chemical products located in the northern suburbs of Philadelphia, is looking for a talented and motivated Product Stewardship and Regulatory Affairs Specialist to help assist in the growth of company to the next level.

Duties and Responsibilities include:

Support new product registrations for Americas region, e.g., TSCA PMN/LVE/Polymer Exemptions, and Canadian DSL/NDSL notifications in close collaboration with R&D and global product stewardship teams. Coordinate TSCA 8c and 8e reviews.

Work closely with technology, manufacturing, commercial, and procurement functions to ensure product stewardship reviews are conducted for raw material and product introduction within the region.

Engage with overseas Product Stewardship colleagues and legal to address Customer declaration requests within agreed business deadlines.

Manage the SDS system with EHS manager and generate SDS for the Americas region, in collaboration with Japan, for commercial and R&D products

Qualifications :

Bachelors degree in chemistry, materials science or related disciplines required. Masters degree preferred.

Five to seven years working knowledge in regulatory Affairs and Product Safety TSCA, FDA

Strong chemistry background. Experience with polymer chemistry is needed.

Fluorchemistry, Fluorgases knowledge/experience is required

Proficient in standard office software and ERP systems.

Willing to travel up to 15% (domestic and international).

If you have 5+ years experience working in a chemical related type environment and are very organized and have the ability to work in a team concept, we want to hear from you.

Be part of a mission-driven team focused on improving the lives of patients worldwide. In this Regulatory Specialist role, youll play a critical part in bringing transformative orthopedic technologies to market, helping surgeons deliver better outcomes, faster recovery times, and higher quality of life for those with musculoskeletal conditions.

Why You Should Apply

• Join a company that thrives on innovation and real-world patient impact
• Collaborate with cross-functional experts in a fast-paced, clinical product environment
• Play a hands-on role in FDA submissions for breakthrough Class II and III medical devices
• Enjoy a culture that blends urgency, teamwork, and a passion for clinical results

What Youll Be Doing

• Drafting and submitting 510(k), IDE, and PMA regulatory submissions
• Partnering with Product Development teams to align on regulatory strategy
• Reviewing clinical data and collaborating with internal teams to support submissions
• Maintaining PMA records, preparing supplements and annual reports
• Training team members and contributing to SOP development and regulatory compliance

About You

• Be able to do the job as described
• Bachelors in health/science-related field; Engineering degree is a plus
• 2-5 years experience in Regulatory Affairs in the medical device industry
• Knowledge of orthopedic medical devices is highly preferred
• Comfortable with FDA regulatory pathways and submission types (Pre-Sub, 510(k), IDE, PMA)
• Strong documentation, review, and cross-functional communication skills

Ultimate Staffing Services is actively seeking a dedicated Regulatory Affairs Specialist to join their client's team in Union City, California. This position will play a crucial role in supporting the Regulatory Affairs department and the broader organization by ensuring compliance with both domestic and international regulations. The ideal candidate will have a strong background in regulatory submissions and experience in the medical device industry.

• Manage and support the Corporate Vision, Mission & Values Statements and company goals.
• Ensure compliance with internal Quality System policies, procedures, and applicable external regulations, including 21 CFR Part 820 Quality System Regulations.
• Compile, prepare, review, and submit regulatory documents, including Device Master files, technical files, and annual reports, under the direction of the Manager, Regulatory Affairs.
• Gather and assemble necessary information for submissions in accordance with regulations and guidelines.
• Maintain a regulatory database and ensure all information is current and accurate.
• Review and present regulatory policies, methods, SOPs, protocols, and reports to ensure regulatory compliance.
• Assist in the implementation and delivery of regulatory documentation.
• Participate in training courses to stay informed on current trends, laws, regulations, and guidelines in medical device development.
• Develop rapport within the company regarding regulatory matters and maintain timelines for submissions.
• Maintain Device Manufacturing licenses as required by regulatory agencies.
• Assist in coordinating responses to requests or questions from government authorities.
  
  

• Bachelor's Degree (or equivalent) in a technical discipline such as engineering, biology, or chemistry.
• 8-10 years of experience as a Regulatory Affairs Specialist, with at least 2 years in the medical device industry.
• Excellent oral and written communication, interpretive, and interpersonal skills.
• Strong attention to detail and the ability to manage multiple tasks.
• Experience with international product registration and knowledge of regulations for cybersecurity, wireless, and sterile products.
• Knowledge of 21 CFR and FDA guidelines (GMPs).
• Proficiency in MS Word, Excel, and PowerPoint.
  
  

The work environment involves an office setting with standard equipment such as computers and telephones. The noise level is typically low to moderate. Reasonable accommodations may be made for individuals with disabilities to perform essential functions.

Monday - Friday, 8:00 AM - 5:00 PM

Salary range: $140,000 - $160,000 per year.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

De Nora is an Italian multinational company, listed on the Euronext Milan stock exchange, a global provider of innovative technologies and solutions, and is recognized as a partner of choice for significant industrial electrochemical processes. Today, it is the worlds largest supplier of high-performing catalytic coatings and insoluble electrodes for electrochemical and industrial applications. De Nora is committed to developing unconventional solutions to achieve the energy transition to decarbonization, the green hydrogen economy, and clean water for everyone. De Nora Water Technologies is a leading solutions provider for water treatment with extensive experience in energy, municipal, and industrial applications worldwide.

OUR VISION: Leverage available talents as catalysts for a sustainable future.

OUR MISSION: Agility & green technologies for value creation.

SUMMARY

The position is responsible for assuring products are compliant to regulations in various Countries around the world by working with internal and external stakeholders and organizing associated activities to completion on-time within budget within the Water Industry. Carefully plan and monitor testing and regulatory compliance activities; prepare technical files and dossier, submit notifications to authorities; verify marketing documents; organize and keep updated the product compliance repository; and monitor regulation changes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. Cross-Functional Collaboration: work closely with other departments including, Product Management, Product Development, Legal, Marketing, Sales, Procurement, Quality Health & Safety and Environmental (QHSE) and Operations to ensure product compliance.

2. Documentation: Collection and review of technical documents. Lead the Dossier preparation and submission to the competent authority respecting defined deadlines.

3. Product Data: Keep the product certification files updated, and in line with company standards. Utilize ERP platform and product data management tools to register information about products accordingly. Provide required technical documents, related to product safety and certification to other functional groups for whenever needed for compliance activities.

4. Regulatory Field: Monitor regulatory trends and stay updated on regulatory developments, norms, rules, and laws applicable to products. Transfer knowledge around regulatory compliance to all interested parties internally.

5. Laboratory and Test: Co-ordinate with various approved test laboratories for testing & approvals as well as products registrations. Obtain quotes and confirm offers from third-party testing and laboratories, and setup purchase requisitions for required activities.

6. Marketing Content: Review wording in marketing documents to ensure compliance of technical data and claims for the intended market applications.

7. Product Lifecycle: Support Product Managers and Product Engineers on writing product specifications and working with external stakeholders on matters regarding technical, safety and performance requirements

8. Operations: Support supply chain operations, including purchasing and quality control, in activities to ensure that all products meet regulatory requirements.

QUALIFICATIONS

Excellent communication is a must, second language (Spanish or Italian) is a plus.

Proven project management and planning knowledge; coordination with multiple stakeholders, teamwork, and attention to detail.

Preferably experience working in B2B with technology company; industrial or environmental

sector.

Proficient in MS Office suite, SharePoint, Teams, OneDrive

Preferably experience working with an ISO-9001 certified organization.

Understanding of water technology market and regulatory requirements is a plus.

Understanding of United States and International Community regulations, particularly US EPA, CE, REACH, RoHS and certifying bodies such as NSF, UL, BV and others is a plus.

EDUCATION and/or EXPERIENCE

Bachelor's degree in Environmental Science or Engineering, and 2-5 years experience in a similar role, or an equivalent combination of education and experience.

CERTIFICATES, LICENSES, REGISTRATIONS

None required. Certified Health & Safety training is a plus.

We are an Equal Opportunity Employer and take pride of our diverse and inclusive environment. We aim to attract and recruit individuals with diverse backgrounds, skills, and abilities, who will enhance the quality of our products and services and contribute to the Groups success. We are committed to prioritize talent, make people feel respected, appreciated, and free to fully express their potential.

• Support U.S. and international product compliance, from ingredients and labeling to certifications.
• Help launch new food and nutrition products by prepping regulatory documentation, reviewing packaging/claims, and coordinating with certifying bodies (e.g., Non-GMO, Kosher, Organic).
• Ensure trade compliance through export filings, Certificates of Analysis, and more.
• Monitor evolving global regulations and track how they impact product formulation, labeling, and market access.
• Contribute to SOP development and broader compliance projectsbecause small improvements ripple big.
  
  

Position Summary:

The Regulatory Affairs Specialist plays a key role in supporting the registration and compliance of pesticide products across state and federal agencies. This position manages all state-level registration activities and assists with federal submissions to ensure timely approvals and ongoing compliance with regulatory requirements.

Key Responsibilities:

• Manage all state pesticide product registrations , including new applications, renewals, label amendments, and sales reporting.
• Support Federal EPA registrations , including submissions for new products, notifications, amendments, CSFs, DCIs, and ABNs.
• Track and monitor all regulatory submissions to ensure timely responses and approvals.
• Maintain documentation for all phases of regulatory activity, including approvals, licenses, and label revisions.
• Review and maintain product labels to ensure compliance with federal and state regulations.
• Manage and update the label system for regulatory compliance.
• Assist in interpreting and applying state, federal, and international pesticide laws and regulations.
• Contribute to continuous improvement initiatives within regulatory processes and systems.
• Adapt to shifting priorities while aligning with company values and departmental strategies.
• Perform other duties as assigned.

Qualifications:

Core Values Alignment: Demonstrates and fosters Kings values: Integrity, Excellence, People Chemistry, Golden Rule, Courage, and Servant-Leadership.

Education: Bachelors degree in chemistry, Biology, or a related scientific discipline (preferred).

Experience: 2+ years in Regulatory Affairs, Compliance, or a technical field (preferred).

• Skills :
• Strong analytical and problem-solving abilities with acute attention to detail
• Excellent organizational and time management skills
• Effective written, verbal, and interpersonal communication
• Ability to work independently and collaboratively across teams

Technology: Proficient in Microsoft 365, Adobe Acrobat Suite, and regulatory tracking systems.

Mindset :

• Proactive and curious, with a drive to challenge conventional thinking
• Comfortable navigating ambiguity and making decisions in evolving environments
• Operates effectively within EOS, embracing clarity, accountability, and structured problem-solving

Compensation:

Estimated annual base salary range: $68,000 $78,000

What you'll do:

• This position will manage all regulatory affairs activities for categories in the US.
• This includes labeling, product development compliance, package development, SDS and ingredients statement generation, customer and regulatory compliance needs, consumer regulatory inquiries, and the safety and efficacy of ingredients.
• Partner with key stakeholders, including but not limited to Marketing, Legal and Product Development, and provide regulatory input in support of product development, ensuring regulatory requirements are communicated and elevated, where appropriate.
• Support QA and Manufacturing related to inspections, recalls and product reviews by regulatory agencies.
• Develop processes/procedures as necessary to support regulatory compliance.
• Prepare and present presentations, both written and oral, to various levels of management.
• Stay abreast of new regulatory developments and communicate relevance to the business.
• Stay abreast of advancements in toxicology research and contribute to the development of safer and more sustainable products.
• Manage workload and prioritize tasks.

What makes you a good fit:

• 10+ years' experience in regulatory affairs.
• Bachelors or Graduate degree in a science related field, law or regulatory science, business administration or public health preferred.
• Strong communication skills
• Ability to manage projects across various departments and teams.
• SAP experience preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams)
• Strong team player with the ability to collaborate effectively across cross-functional stakeholders

Required Citizenship / Work Permit / Visa Status
US Citizen, Permanent Resident, Green Card Holder

Must-Haves
8+ years working in regulatory affairs in the consumer goods industry, must be within chemical related product lines (laundry detergents, household cleaning products, etc.)
8+ years experience working with both federal and state regulatory compliance
5+ years with product labeling experience - need solid knowledge of labeling review and compliance
BS degree in technical field