Description
Job DescriptionA San Francisco Bay Area Class II medical device company is seeking a Regulatory Affairs Senior Specialist. The Senior Specialist will interact with the Regulatory Affairs Management team in prioritizing regulatory activities and projects to meet department and corporate goals. The ideal candidate will have experience with IDE and 510k.
Primary Responsibilities:
- Serving as regulatory affairs liaison on cross-functional teams.
- Create, write, and submit regulatory paperwork in theUnited States,Europe, and other International markets including IDE, 510k, and Technical Files.
- Work closely with the Management with preparation of IDE and 510k submissions.
- Work directly on approving labeling and packaging.
- Contribute to the development of the project plan for design control.
- Represent the Regulatory Affairs team in Specifications and Product Plans.
Job Requirements:
- Thorough understanding of U.S. and International regulatory requirements including Design Control, labeling, medical device submissions, and quality control.
- Self-starter, team player, and exceptional attention to detail.
- B.A./B.S. (Life science or engineering preferred)
- 3+ years of Regulatory Affairs, Clinical Affairs, or Quality Assurance experience within a medical device company.
To find out more about Real please visit www.realstaffing.com