Senior Regulatory Affairs Specialist

Our customer is looking for a Senior Regulatory Affairs Specialist to join a team of 7 and supporting the product submissions, regulatory guidance, and registering products.

Duties Include:

Maintain and establish regulatory functions for medical device and environmental compliance.

Uphold Quality Management System for domestic and international standards.

Document corporate regulatory practices in the Quality Management System.

Assist in product development with regulatory analysis and strategy creation.

Register and maintain product registrations with relevant agencies.

Guide Engineering on Design History Files, Device Master Records, and Technical Files maintenance.

Experience:

Bachelor's degree in Science, Engineering, or related field preferred.

5+ years of experience in regulatory affairs required.

Knowledge of 21CFR 820, ISO13485, and MDR QMS preferred.

Experience w 510(k) submissions / EUMDR