Medical Device Compliance Manager

2 days ago


Boston, Massachusetts, United States Jobot Full time

Jobot is a well-established consulting firm providing solutions to medical device companies, pharmaceuticals, and biologics. We are seeking a Medical Device Compliance Manager to join our team.

About the Company

At Jobot, we pride ourselves on being a dynamic and forward-thinking organization that values innovation and excellence.

As a Medical Device Compliance Manager, you will play a vital role in ensuring our organization's compliance with FDA and other relevant regulations.

The estimated salary for this role is $90,000 - $115,000 per year, depending on location and experience.

Responsibilities
  • Develop and implement regulatory strategies and processes to ensure compliance with FDA and other relevant regulations.
  • Manage all aspects of quality assurance, including developing and implementing quality control systems, conducting audits, and managing corrective and preventive actions.
  • Liaise with regulatory bodies and other external stakeholders, representing the organization in all regulatory matters.
  • Review and approve all regulatory submissions, ensuring their accuracy and completeness.
Qualifications

• Bachelor's degree in a scientific discipline

• Minimum 3-5 years of experience in regulatory affairs in the medical device industry, including experience with FDA regulations

• Excellent knowledge of regulatory requirements and quality assurance principles



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