What are the responsibilities and job description for the Regulatory Affairs Specialist position at Katalyst CRO?
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.
