Sr. Regulatory Affairs Manager ( Enterprise Cardiology Solutions )
The successful candidate will assist in preparation of regulatory submissions related to Enterprise Cardiology. The candidate will represent Regulatory Affairs on Product Development Teams (PDP) and/or Design Change Teams for the Enterprise Cardiology solutions in Ann Arbor, Michigan.
- Responsible to ensure regulatory compliance (QSR, ISO, CMDR and other applicable country regulations) are met through the development, implementation and delivery of Syngo Dynamics
- Responsible to assess regulatory impacts of the design and manufacturing changes and prepares/submits 510(k)s, NFJs, DOC’s and other country specific documentation as needed.
- Responsible to ensure all product labeling meets regulations through external materials i.e. Marketing brochures, intranet/internet publications, User documentation etc.
- Participates to drive and implement Lean initiatives for regulatory relevant processes.
- Participates and or supports Quality management in recommending processes changes or risks that ensure alignment with strategic direction and or QMS compliance.
- Participates in audits and inspections by regulatory authorities and certification/accreditation bodies.
- Performs advanced areas of work for the professional field. Able to manage multiple projects, communicate updates, and meet milestones in a timely fashion. Displays a high level of critical thinking in bringing successful resolution to high impact, complex, and/or cross functional problems.
- Strong communication skills to communicate clearly and professionally to various levels of management throughout the business.
Required Knowledge/Skills, Education and Experience:
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
- 8-10 years of Regulatory experience with the development of medical devicesrequired.
- Experience with U.S. FDA 510k submissions required.
- Knowledge and experience with global registrations a plus
- Demonstrates a good grasp of QMS knowledge and quality and lean principles and applies through successful completion of assignments. Value stream mapping experience a plus.
- Strong interpersonal, communication and organizational skills required
- Must be able to set priorities as well as adapt to changing priorities
Requisition Number: 214308