Regulatory Affairs Specialist

Job Title

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 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.
• 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.

Requirements:

• 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.