3,903 Regulatory Specialists jobs in the United States

• Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions.
• Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions.
• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
• Evaluate the risk of proposed regulatory strategies; may offer solutions.
• Reviews proposed labeling for compliance with applicable US and international regulations.
• Writes/manages the development of package inserts.
• Reviews and evaluates promotion and advertising material for compliance with applicable regulations.
• Reviews proposed product changes for impact on regulatory status of the product.
• Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions.
• Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions.
• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
• Expected Areas of Competence.
• Demonstrated strong writing and communication skills.
• Strong attention to detail, ability to multi-task.
• Knowledge of overall business environment, the orthopedic industry, and the marketplace.
• bility to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs, and combination products.
• bility to function well as a member of the team and build relationships between RA and other areas of the organization.
• ble to identify risk in Regulatory strategies.
• Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred.
• Basic computer skills, including Microsoft Office Suite.

• US bachelor's degree in life sciences, technical (engineering) or related field (or non-US equivalent).
• minimum of 3 years' experience in Regulatory Affairs
• dvanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred.
• Regulatory Affairs Certification (US or EU) preferred.
• combination of education and experience may be considered.

• Responsible for preparing and submitting regulatory documentation to the FDA for Class II and III medical devices, ensuring compliance with relevant regulations and supporting product development teams throughout the submission process.
• Collaborate with cross-functional teams to prepare and submit 510(k), IDE, and PMA documentation to the FDA.
• Review and approve regulatory documentation including labeling, drawings, and change orders for compliance.
• Maintain and update approved PMAs, including supplements and annual reports.
• Assess regulatory pathways for new or modified products and approve supporting documentation.
• Train new staff on regulatory processes and contribute to the development of SOPs.

• Bachelor's degree in a health or science-related field; Engineering degree preferred.
• 2-5 years of experience in Regulatory Affairs within the medical device industry, ideally orthopedic devices.
• Strong knowledge of FDA regulatory submissions including 510(k), Pre-Sub, IDE, and PMA.
• Experience with clinical data review and regulatory impact assessments of product changes.
• Familiarity with labeling and promotional material review for regulatory compliance.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Teams).
• Strong organizational and time management skills; ability to manage multiple priorities independently and collaboratively.

• Salary: $80,000-$90,000 depending on experience
• Comprehensive Benefits : Medical, Dental, Vision, 401(k), PTO, vacation, and sick leave in accordance with applicable laws

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

We are looking for a Regulatory Affairs Specialist in Georgia to join our growing team. This role is open to graduates with a Life Sciences degree and/or anyone with experience in the relevant areas.

Responsibilities:

• Assist the project leads in the Regulatory Strategy & Procedure Management Practice Area in operational tasks and all aspects of technical delivery and project management.
• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.
• Support with preparation, review and compilation of documents within the framework of regulatory affairs projects.
• Communicate with clients and Health Authorities in close cooperation with the respective lead.
• Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
• General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management.
• Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.
• Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.

• Basic experience in area of responsibility or demonstrable capability from a similar field; ability to acquire knowledge "on-the-job".

• University degree in Life Science

• Local experience on the Georgian market in terms of lifecycle management. (beneficial), Pharmacovigilance and/or Quality Assurance or Quality Control experience (beneficial)
• Ability to work according to project plan and escalate potential issues according to agreed communication plan.
• Structured way of working; limited latitude within established set of procedures, may determine priorities with general supervision.
• Resolves routine (and some non-routine) problems in a thorough and timely manner.
• Attention to detail. High service orientation.
• Ability to prioritize and manage own time and tasks.
• Ability to convey a positive message about Pharmalex
• Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise. Confident appearance.
• English business fluent & local language (as appropriate). Fluent in Russian (benefit).

Bridgeport CT

$100,000.00 - $125,000+ Bonus + Paid Relocation

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.
• It is anticipated that this role will transfer to First Quality approximately Q4 2025.

Qualifications

• 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

Benefits

• Health Insurance: affordable plans for medical, dental, vision and wellbeing starting on day 1
• Work-Life Balance: Paid time off including sick, vacation, holiday and volunteer time, flexible & hybrid work policies (depending on role), and vacation buy / sell program
• Financial: 401k matching, employee share plan with voluntary investment and the company's matching shares, annual performance bonus, service awards and student loan reimbursement
• Family Support: 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships
• Career Growth: diverse national and international growth opportunities, access to thousands of skills development courses, and tuition reimbursement

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Title:Regulatory Affairs Specialist

Location:North Haven, CT
Duration:7+ months (Possibility of extension)

Job Roles & Responsibilities

• Compiles all materials required in submissions, license renewal, and annual registration.
• Technical file remediation, DHF experience, Microsoft project experience a plus as we need to build regulatory plans in Gantt.
• Assist in submission preparation (e.g. 510ks, Change Notices to Notified Bodies). Overall knowledge of regulatory documentation.
  

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # -
Email id seema @|
LinkedIn:
Gold Seal JCAHO Certified for Health Care Staffing
INC 5000s FASTEST GROWING, PRIVATELY HELD COMPANIES (8th Year in a Row)