US bachelor's degree in life sciences, technical (engineering) or related field (or non-US equivalent).
Minimum of 3 years' experience in Regulatory Affairs.
Advanced experience in preparing dossiers for product registrations outside the US; FDA submission preparation preferred.
Regulatory Affairs Certification (US or EU) preferred.
Strong writing and communication skills.
Responsibilities
Contribute to the FDA regulatory submission process and assist in electronic submissions.
Lead the development of product registration dossiers for international markets.
Provide regulatory direction to project teams and develop strategies for new products.
Evaluate risks associated with proposed regulatory strategies and offer solutions.
Review labeling for compliance with US and international regulations.
Develop and manage package inserts for products.
Review promotional and advertising materials to ensure regulatory compliance.
Benefits
Opportunities for professional development in a growing field.
Collaborative team environment fostering cross-departmental relationships.
Exposure to diverse regulatory landscapes, enhancing global knowledge.
Potential for career advancement in regulatory affairs.
Full Job Description
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.
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.
Requirements:
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.
