Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Vakula Technologies Inc
United States
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Job Role: Senior Regulatory Affairs Specialist
Contract: W2
Location: Remote
Responsibilities
Job Role: Senior Regulatory Affairs Specialist
Contract: W2
Location: Remote
Responsibilities
- Develop and execute regulatory strategies for pioneering medical devices.
- Provide expert guidance and support in obtaining regulatory approvals and clearances for Class II & Class III devices.
- Collaborate with other areas in business such as Quality, R&D, and Clinical departments.
- Prepare with the team for meetings with FDA and Notified Bodies.
- Contribute towards submissions and regulatory files.
- Engage with regulatory authorities and agencies to facilitate product approvals and resolve regulatory issues.
- 3+ years working in Regulatory Affairs with Medical Devices (Orthopedic implantable devices highly preferred).
- Demonstrated excellent communication and presentation skills.
- Detailed knowledge of FDA, EUMDR, and Health Canada Regulatory Requirements.
- Experience preparing for meetings with FDA and Notified Bodies.
- Contributed to regulatory projects (510k, De Novo, IDE, PMA, and CE Mark).
- Extensive knowledge of regulations, such as: ISO 13485, ISO 62304, CFR 820, ISO 60601-1.
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Seniority level
Associate -
Employment type
Contract -
Job function
Legal -
Industries
IT Services and IT Consulting
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