Regulatory Affairs Specialist
Company Summary:
My client, a rapidly growing and leading medical device company focuses on supporting trauma care organizations and providing first responders with the equipment they need to save lives! My client is looking to add a Regulatory Specialist to the team! They are located in Harrisburg, NC and they are seeking a hybrid candidate.
The Regulatory Affairs Specialist will be responsible for:
- Executing established regulatory strategy to lead successful registration and life-cycle management
- Reviewing labeling, training, promotional materials, and change orders to assess regulatory impact of product changes on US/international regulatory strategy and submissions
- Supporting post market regulatory compliance activities
- Complying with applicable FDA/international regulatory laws and standards and ensuring relevant ISO and FDA export requirements are met
The Regulatory Affairs Specialist should have the following qualifications:
- 3+ years of Regulatory Affairs experience (Medical device and/or pharmaceutical)
- Strong knowledge of domestic and global regulations/guidance
- Successful interactions with global regulatory authorities
- Knowledge of FDA, MDD, EU MDR
