Regulatory Specialist Sr

generis tek • San Diego, CA

1d • Onsite

About The Position

Generis Tek is seeking a Regulatory Specialist Sr for a contract role in San Diego, CA. This position involves participating in continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, and regulatory policy and intelligence. The role ensures timely approval of new medical devices and continued approval of marketed products. The Regulatory Specialist Sr will serve as a regulatory representative to cross-functional teams and advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, and appropriate regulations and interpretations.

Requirements

• 7 years of experience in Medical Device Regulatory Affairs
• Considered as highly experienced with regulatory change assessments.
• Working knowledge in US Medical Device Submissions

Responsibilities

• Participates in continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, regulatory policy and intelligence.
• Ensures timely approval of new medical devices and continued approval of marketed products.
• Serves as regulatory representative to cross-functional teams.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed