- GRAIL (Durham, NC)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Preferred… more
- United Therapeutics (Research Triangle Park, NC)
- …individual expertise and mentoring or developing a member of your team. The Associate Director , QA Engineering will provide advanced support and subject matter ... across multiple functional groups (eg, Research and Development, Manufacturing, Validation, Regulatory Affairs , etc.). Negotiate and manage expectations across… more