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RadNet · 20 hours ago

Regulatory Affairs Manager

Somerville, MA

Full-time

Hybrid

Senior Level, Lead/Staff

9+ years exp

RadNet is a company focused on regulatory affairs, and they are seeking a Regulatory Affairs Manager to execute regulatory strategies and ensure compliance with global regulations. This role involves overseeing regulatory submissions, mentoring team members, and providing strategic input on product lifecycle planning.

Health CareHealth DiagnosticsHospitalMedical

Responsibilities

Oversee the day-to-day functions of the US and EU based Regulatory Affairs team members

Contribute to and execute the regulatory strategies for existing, new and modified medical and non-medical devices

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 device

Leads and manages regulatory submissions, including US 510(k)s submissions, and technical files for CE marking, including Regulatory Body interactions

Mentor and provide guidance to their direct reports and cross-functional product development teams on regulatory requirements, specifically for the US, UK ,and EU markets

Work closely with business partners and regulatory team members to ensure compliance for and support of OUS 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

Assist in SOP development and review in support of "next-gen" product offerings

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

Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action

Ensure compliance with product post marketing requirements

Qualification

Regulatory AffairsFDA Quality System RegulationsRegulatory FilingsMedical Devices RegulationsClinical Studies KnowledgeCommunication SkillsTeam Leadership

Required

Bachelor's degree in relevant field (or equivalent experience)

9 - 10 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

Excellent written and oral communication skills

Preferred

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