DeepHealth

Senior Regulatory Affairs Specialist

DeepHealth

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Salary

💰 $120,000 - $150,000 per year

Job Level

Senior

About the role

  • Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
  • Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
  • Assist in SOP development and review in support of "next-gen" product offerings.
  • Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
  • Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval.
  • Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.
  • Assist in preparation and review of regulatory submission to authorities.
  • Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
  • Utilize technical regulatory skills to propose strategies on complex issues.
  • Ensure compliance with product post marketing requirements.
  • Review product labeling to ensure compliance with relevant regulatory requirements.
  • Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
  • Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.
  • Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes.
  • Ensuring timely submission of adverse events to the appropriate regulatory bodies.

Requirements

  • Bachelor’s degree in relevant field (or equivalent experience)
  • 8 - 12 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, and Traditional and Special 510(k) filings for Software as Medical Device.
  • Experience with US FDA Class I and II medical devices.
  • Additional experience with FDA Class III devices and OUS device classification a plus.
  • Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections.
  • 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 & Tools
regulatory submissionsSOP developmenttechnical documentationclinical evaluation reportsrisk management reportsFDA Quality System Regulations21 CFR 1121 CFR 820ISO 13485MDSAP
Soft Skills
communication skillsguidanceleadershipcollaborationstrategic inputtechnical guidancementoringproblem-solvingevaluationrecommendation