Medical Device Regulatory Specialist

Urgent
Application ends: May 12, 2026
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Job Description

We are seeking a knowledgeable and detail-oriented Medical Device Regulatory Specialist to ensure compliance with global regulations for our medical device products. This role involves preparing regulatory submissions, maintaining compliance, and liaising with regulatory agencies to facilitate product approvals. The ideal candidate will have a strong understanding of medical device regulations and the ability to work in a fast-paced, cross-functional environment.

Key Responsibilities:

  • Prepare, review, and submit regulatory documentation, including 510(k) premarket notifications, CE Mark submissions, and Technical Files.
  • Ensure compliance with FDA, MDR/IVDR (EU), and other global medical device regulations.
  • Collaborate with R&D, quality assurance, and manufacturing teams to gather and verify regulatory information.
  • Monitor changes in global medical device regulations and ensure timely implementation of updates.
  • Serve as the point of contact with regulatory authorities, addressing queries and facilitating audits.
  • Maintain detailed records and documentation of regulatory submissions and correspondence.
  • Provide regulatory guidance throughout the product development lifecycle to ensure compliance.

Qualifications:

  • Bachelor’s degree in Biomedical Engineering, Life Sciences, or a related field.
  • 3-5 years of experience in regulatory affairs with a focus on medical devices.
  • Comprehensive knowledge of FDA 21 CFR Part 820, ISO 13485, and global medical device regulations.
  • Experience with 510(k), PMA, and CE Marking processes.
  • Strong analytical skills and attention to detail.
  • Excellent communication and organizational abilities.

Benefits:

  • Competitive salary and comprehensive benefits package.
  • Opportunities for professional growth and development.
  • Health, dental, and vision insurance.
  • Collaborative and supportive team environment.

How to Apply:
Submit your resume and a cover letter detailing your experience in medical device regulatory affairs and your qualifications for the role.