We are currently seeking a Regulatory Affairs Specialist for our client based in Charlotte, NC. The successful candidate will be responsible for working closely with the Director to ensure that all submissions are compliant with regulatory requirements.
The Regulatory Affairs Specialist will be responsible for the following:
- Developing regulatory strategies for new products and product changes.
- Preparing and submitting regulatory submissions for new and modified products.
- Ensuring that all device labeling and promotional materials are compliant with regulatory requirements.
- Monitoring and interpreting changes in regulatory requirements.
- Providing regulatory guidance to cross-functional teams.
Qualifications/Skills:
- Experience in regulatory affairs with pharmaceuticals and medical devices is preferred.
- Ability to work independently and as part of a team.
- Excellent written and verbal communication skills.
- Strong attention to detail.
- Minimum of 3 years of experience in regulatory affairs.
