Regulatory Affairs Project Manager
With our medical device client, this position is responsible for providing leadership and management of regulatory projects, within the global business unit, to support the development and marketing of products/accessories. In addition, the position will communicate regulatory strategy, project requirements, supervise the development and creation of labeling, and provide guidance and consultation for domestic and international regulations and interact with governmental agencies. This position focuses on new product development project support and submission activities.
Principal Duties and Responsibilities
- Manages FDA regulatory submission process; may author and publish electronic submissions.
- Manages the development of dossiers for registration of products in countries outside the U.S; may author and publish electronic submissions.
- Provides regulatory and clinical direction to development project teams as a core team member, or lead a project team; develops and communicates regulatory and clinical strategy for new products.
- Oversees development of, and may develop and review, proposed labeling for compliance with applicable U.S. and international regulations.
- Supports, supervises, and participates (as necessary) in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status of the product.
- Interprets and applies FDA regulations to business practices and provides regulatory/clinical input, advice, and guidance to the organization.
- Establishes RA policy and procedures and ensures compliance with them.
- Keeps all areas of the organization informed of regulatory requirements and emerging issues which may affect the registration approval of products.
- Communicates with Regulatory agencies.
- Responsibility for oversight and prioritization of departmental tasks and projects.
Expected Areas of Competence
- Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with Regulatory agencies, superiors, peers, and direct reports.
- Strong attention to details, and ability to multitask.
- Understands the overall business environment, medical software, the medical device industry and the marketplace.
- Mastery of relevant regulations and ability stay abreast of regulations pertinent to clinical research, medical devices, biologics, software, drugs and combination products.
- Strong computer skills.
- Able to identify and assess business risks and develop Regulatory strategy.
- Strong product knowledge.
- Ability to build relationships with other areas of the organization.
- Ability to negotiate with Regulatory agencies, management, and other groups as necessary.
- Ability to lead a team, influence others and. Strong organizational skills and development project experience qualify the occupant to lead teams and handle increasing levels of responsibilities
- US Bachelor’s (or non-US equivalent) degree in Life Sciences, Engineering or related field
- A minimum of 6 years of experience in Regulatory Affairs
- Experience in orthopaedic or medical device strongly preferred
- Regulatory Affairs Certification (US or EU) preferred.
- Combination of education and experience may be considered