Senior Regulatory Affairs Specialist - (Medical Device) - Hybrid/Onsite position in Georgia
Our client is looking to expand their Regulatory team as they continue their growth. This is an opportunity to be hands on with FDA and EUMDR submissions.
You MUST have domestic experience with 510k submissions and EU Technical Files and willing to work onsite 3 days a week in the Atlanta area.
Responsibilities:
- Develop and execute regulatory strategies for unique medical devices.
- Provide expert guidance and support in obtaining regulatory approvals and clearances for Class II in US Devices.
- Collaborate with other areas of the business such as Quality, R&D, Marketing, and Clinical departments.
- Lead meetings with the FDA. Lead and author entire submissions and regulatory files.
- Engage with regulatory authorities and agencies to facilitate product approvals and resolve regulatory issues.
- Lead US 510k submissions.
Qualifications:
- 3+ years of experience working in Regulatory Affairs with Medical Devices.
- Demonstrated excellent communication and presentation skills.
- Detailed knowledge of FDA Regulatory Requirements.
- Experience as the main point of contact with FDA and Notified Bodies.
- Track record of building and guiding Submissions, and Strategies.
- Experience working directly on a 510k submission and EUMDR registrations.
- Extensive knowledge of regulations, such as: ISO 13485, ISO 62304, CFR 820
Unfortunately, our client cannot support sponsorship visas at this time.
If you would like to learn more about this Regulatory Affairs Specialist opportunity, apply directly or reach out to:
wjlynch@barringtonjames.com
