The opportunity
The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets.
What you'll do
Understands and interprets U.S. and EU and international medical device and: in vitro diagnostic device (IVD) regulatory requirements.
Provides guidance on requirements to product development teams.
Develops strategies for submissions to FDA and other regulatory agencies.
Provides risk assessments and regulatory options.
Prepares U.S. regulatory submissions necessary for new product market: clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements. Prepares and/or compiles information required by ex-U.S. regulatory associates to register or license products outside the U.S. Interacts and negotiates with U.S. regulatory agencies.
Coordinates the preparation of additional data/information requested by: regulatory agencies and prepares appropriate responses to all such requests.
What they're looking for
- Participates in the development and review of product release documents.
- Reviews clinical protocols to assure collection of appropriate data for regulatory submissions.
- Periodically monitors status of clinical studies and reviews analysis of resultant clinical study data.
- Based on these data and considering the regulatory requirements, recommends appropriate courses of action.
