Job Summary
A healthcare company needs applicants for an opening for a Remote Regulatory Affairs Manager.
Individual must be able to fulfill the following responsibilities:
- Develop regulatory strategies for U.S. and international markets
- Review and interpret changes in regulatory policies for impact
- Collaborate with Quality and Product teams to continuously improve and develop processes
Skills and Requirements Include:
- 5+ years in regulatory affairs in a regulated industry
- Solid understanding of ICH GCP, ISO 14155, HSP, HIPAA, CFR Title 21
- Solid understanding of Clinical Trials Regulation under EMA
- Successful preparation and submission of 510(k)s and international documents or registrations
- Thorough knowledge of medical device design control and risk management processes
- Knowledge of clinical and data requirements in support of regulatory filings
