Regulatory Affairs Manager - Compliance
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POST DATE 8/23/2016
END DATE 12/19/2016
JOB DESCRIPTIONJob Summary
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%