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Senior Regulatory Manager

Job Description

Melio Life Science has partnered with a leading innovator in the medical device industry, committed to advancing healthcare through cutting-edge technologies. They are seeking a highly skilled and experienced Senior Regulatory Manager to join their dynamic team.


The successful candidate will play a pivotal role in ensuring compliance with regulatory requirements and guiding their products through the regulatory approval process.

Key Responsibilities:

  • Develop and implement regulatory strategies for new and existing medical devices.

  • Prepare and submit regulatory filings, including 510(k)s, PMAs, and other regulatory submissions, to regulatory authorities such as the FDA.

  • Ensure ongoing compliance with global regulatory standards and requirements.

  • Collaborate with the quality assurance team to maintain and enhance the company's quality management system.

  • Work closely with R&D, clinical, quality, and manufacturing teams to ensure regulatory requirements are considered throughout the product lifecycle.

  • Lead and manage a team of regulatory professionals, providing guidance, mentorship, and support.


  • At least 2 years of EU MDR/ SaMD experience.


  • Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.

  • 8+ years of experience in medical device regulatory affairs.

  • In-depth knowledge of FDA regulations and international regulatory requirements.

  • Experience with managing teams of at least 5 people.

  • 3 years of managerial experience.

  • Proven track record of successful regulatory submissions and approvals.

  • Strong project management and organizational skills.

  • Excellent communication and interpersonal skills.

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