A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics. But we don't stop at healthcare; our Non-Destructive Testing ( NDT ) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly. Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while working in a dynamic, flexible environment that fuels your creativity and drive. Our headquarters is in Lexington, Massachusetts, an inspiring healthcare research hub in a historic town. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."
Visit:
https://www.fujifilm.com/us/en/about/region/careers Overview This position is intended to provide Regulatory Affairs support to
FUJIFILM
Healthcare AmericasCorporation. This position supports full, ongoing compliance to all applicable U.S. Food and DrugAdministration (U.S. FDA ) medical device regulatory requirements, applicable
ISO 13485
standardrequirements and all other applicable laws, regulations, and standards. External US Duties and responsibilities + Designated Responsible Personnel for Device Marketing Authorization and Facility Registration to include proper registration, listing, licensing, notification and approval information submission to regulatory authorities or authorized representative participating in the Medical Device Single Audit Program ( MDSAP ) ( ISO 13485/ MDSAP ) + Designated Joint Responsibility pursuant of Article 15 of the European Union Medical Device Regulation (EU MDR (EU) No. 2017/745) + Perform Pre-Market
U.S. FDA
submissions (510(k) and PMA ) in accordance with the product plan. + Provide feedback and recommendations to design teams regarding deciding when to submit a 510(k) for a change to an existing medical device. + Provide feedback and communicate the conclusion to business units regarding regulatory documentation of new product and supplier assessment. + Prepare European Union Technical Documentation and International Reg To view full details and how to apply, please login or create a Job Seeker account
