An innovative medical device company focused on aesthetics products is looking for a Sr. Regulatory Affairs Specialist due to a large growth initiative.
The Regulatory Affairs Specialist will have the following responsibilities
- Develop and manage global regulatory strategies to maximize the value of the products/projects
- Manages the U.S. FDA Class II medical device submissions
- Global responsibilities for device registrations, supports medical device registrations in Rest of World
- Supports ISO audit to maintain ISO 13485:2016 certification, MDSAP, FDA, TGA, and Health Canada, audits (and others)
- Responsible for EU Medical Device Directive 93/42/EEC and Class I, IIa, and IIb medical devices, transition to MDR
- Responsible for all updates to tech files.
- Assists the Medical Affairs department with documentation
- Supports all the regulatory aspects of the product lifecycle, Post Market Surveillance
- Yearly establishment registration and device listing updates and renewals
- Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes
- Provides solutions to a range of regulatory issues and creates plans to execute
- Provides high quality regulatory support for assigned products/projects
- Partners with internal and external stakeholders to align on an optimized regulatory strategy to achieve business objectives.
- Develops documents that are clear, concise, and complete to facilitate reviews/approvals
This is a 6 month contract to hire position.
Sthree US is acting as an Employment Business in relation to this vacancy.