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. Responsibilities:
- 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
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.