Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Strategizing and implementing global regulatory initiatives essential for acquiring and sustaining worldwide regulatory approvals.

• Develop detailed regulatory strategies for new devices and markets.

• Assess and provide input on documentation to ensure adherence to regulatory standards.

• Execute and uphold regulatory submissions by collaborating with both internal and external teams.

• Communicate project goals with team members and serve as a regulatory expert.

⛳️ Requirements

• B.A. or B.S. degree in a life science discipline (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or a related field.

• A minimum of 2 years of experience in medical device regulatory affairs or quality assurance.

• Familiarity with the current regulatory landscape.

• Practical knowledge of FDA regulations and guidelines.

• Capability to assess information to ensure compliance with applicable standards, laws, and regulations.

• Willingness to travel up to 5% of the time.

🏝️ Benefits

• Health insurance.

• Life and disability insurance.

• 401(k) contributions.

• Paid time off.