DeepHealth

Senior Regulatory Affairs Principal – Autonomous

DeepHealth

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Salary

💰 $130,000 - $160,000 per year

Job Level

Senior

About the role

  • Develop and execute the regulatory strategy for DeepHealth’s high risk (FDA Class III) devices.
  • Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for high risk medical devices.
  • Lead and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions, Premarket Approvals (PMA) submissions, supplements, and reports, including Regulatory Body interactions.
  • Work closely with business partners and regulatory team members to ensure compliance for and support of regulatory submissions and filings.
  • Monitor and interpret evolving global regulations, standards, and guidance documents to ensure the company’s regulatory compliance, translating them into action steps for the organization.
  • Create and ensure maintenance of technical documentation as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.

Requirements

  • Bachelor’s degree in a life science, engineering, or related scientific field is required.
  • An advanced degree or Regulatory Affairs Certification is preferred.
  • 13 - 17 years working in a regulated industry (FDA and Software as a Medical Device preferred).
  • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
  • Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, Traditional 510(k) filings, and Premarket Approval for Software as Medical Device.
  • Experience with US FDA Class III devices required; OUS device classification preferred.
  • Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, product Deficiency Response meetings, and regulatory inspections.
  • Experience with FDA’s Total Product Life Cycle Advisory Program (TAP) and Breakthrough Designation a plus.
  • International submission experience in Australia, Canada, Brazil, and Japan for high risk devices.
  • Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56.
  • Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred.
  • Excellent written and oral communication skills.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory strategy developmentregulatory submissionsFDA Q-submission510(k) submissionsPremarket Approvals (PMA)technical documentationdrafting regulatory filingspre- and post-market clinical studiesMedical Devices Regulations (MDR)ISO 13485
Soft skills
strategic inputtechnical guidancecompliance supportmonitoring regulationscommunication skills
Certifications
Regulatory Affairs Certification