Regulatory Affairs Manager - Compliance
Responsible for managing departmental projects, providing guidance and regulatory support for product and process changes and their associated impact on compliance with domestic and international regulations, and managing a staff of regulatory professionals. An understanding of orthopedic products and their use as well as an understanding of associated regulations and their application is required.
Principal Duties and Responsibilities
-Keeps all areas of Zimmer Biomet informed of global regulatory requirements and emerging issues which may affect the registration approval of products.
-Provides regulatory direction to functional business partners, such as development and operations project teams as a core team member; develops regulatory strategy for new or changing products which may require submissions, technical files and dossiers for global product registration.
-Coordinates with team, regional and functional representatives in support of identification and implementation of process changes as needed for ensuring alignment with new and evolving regulatory requirements or industry trends/best practices.
-Interacts with Regulatory and Governmental agencies as a Corporate Regulatory representative, including but not limited to site audits and inspections, registrations and certifications.
-Provides Audit Readiness training across the Zimmer Biomet RA organization.
-Provides support for Corporate Regulatory CAPA investigations, verifications and implementation of solutions leading to successful closures. Evaluate and communicate compliance risks and possible solutions.
-Generates corporate communications, including status reports and analyses, to the regulatory management team and department, in addition to functional business partners.
-Directs and oversees the work of regulatory professionals, including training, mentoring and ensuring professional development.
-Assigns RA professionals to serve on project teams as core team members; provides guidance and communicates regulatory strategy for affected products.
Expected Areas of Competence
-Strong writing and communication skills; ability to communicate effectively at multiple levels, including Regulatory agencies
-Knowledge of medical device products and regulations and ability to interpret them.
-Ability to lead a team, influence others, and handle increasing levels of responsibility.
-Ability to build relationships with other areas of the organization (i.e. marketing, research).
-Understands the overall business environment, the orthopedic industry, and the marketplace.
-Ability to identify and assess business risks to develop Regulatory strategy
-Ability to manage/supervise employees
-Must have strong attention to detail.
-Strong computer skills.
* Bachelor's Degree in life sciences, technical (engineering) or related field or non-US equivalent.
* Advanced degree strongly preferred
* A minimum of 6years of experiencerequired in a Regulatory Affairs capacity
* Regulatory Affairs Certification (US or EU) preferred
* Experience in the areas of drugs, biologics, and combination products regulations is strongly preferred
* A combination of education and experience may be considered
Up to 15%