Regulatory Affairs Specialist
Posted on :
17-11-2022
Employer Active
1 Vacancy
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Job Description
Req ID : 1684120
Responsibilities:
- 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 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
- Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products
- Ability to function well as a member of the team and build relationships between RA and other areas of the organization
- Able 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).
- A minimum of 3 years' experience in Regulatory Affairs
- Advanced 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
- A combination of education and experience may be considered.
Employment Type
Full Time
Key Skills
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