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Conformal Medical · 4 days ago

Senior/Principal Regulatory Affairs Specialist

Nashua, NH

Full-time

Onsite

Senior Level

5+ years exp

Conformal Medical, Inc. is a fast-growing, clinical-stage medical device company focused on developing innovative left atrial appendage occlusion technology. They are seeking a Senior or Principal Regulatory Affairs Specialist to manage regulatory activities for clinical trials and submissions necessary for marketing authorization, ensuring compliance with post-commercial regulatory requirements.

Health CareMedicalMedical Device

Responsibilities

Draft and review regulatory submissions, including IDE supplements and reports, pre-submissions, and PMA modules

Contribute to PMA strategy and planning, including development of submission timelines, content outlines, and data readiness assessments

Participate in FDA interactions, teleconferences, and face-to-face meetings, including pre-meeting preparation and post-meeting documentation

Support development and execution of EU MDR regulatory strategy for a Class III cardiovascular device

Contribute to Technical Documentation (Annex II & III), including clinical evaluation, GSPR mapping, and risk management inputs

Support interactions with the Notified Body, including responses to questions and audit preparation

Provide regulatory guidance for ongoing international clinical trial activities & review clinical documents (protocols, IBs, ICFs, SAPs) for regulatory compliance

Advise product development teams on regulatory requirements, test protocol development, and reports that will be used to support regulatory submissions

Collaborate closely with Quality and Engineering on design controls and change management

Track regulatory commitments, milestones, and deliverables across regions

Review and approve advertising and promotional items and device labeling to ensure regulatory and company policy compliance

Maintain annual licenses, registrations, listings

Qualification

Regulatory AffairsClass III cardiovascular devicesIDE clinical trialsPMA pathwaysEU MDR submissionsLife sciences degreeEngineering degreeRAC-Devices certificationWriting skillsFast-paced environment