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CEFALY Technology · 2 days ago

Regulatory & Clinical Affairs Manager

Darien, CT

Full-time

Hybrid

Mid, Senior Level

$90K/yr - $120K/yr

5+ years exp

CEFALY Technology is transforming migraine care with innovative, drug-free, and non-invasive therapeutic solutions. The Regulatory & Clinical Affairs Manager is responsible for overseeing regulatory compliance and clinical affairs activities across the product lifecycle, serving as a key liaison between internal leadership, clinical consultants, quality, and external regulatory authorities.

Medical Device

Responsibilities

Manage administrative aspects of clinical trial and clinical affairs activities, serving as a liaison with the Medical Affairs and Clinical teams

Facilitate communication and coordinate meetings to ensure alignment between CEFALY leadership and external clinical consultants and advisors

Support annual regulatory obligations, including device and establishment registrations with regulatory authorities such as the U.S. FDA and Health Canada

Assist with preparation for and participation in regulatory audits and inspections (e.g., FDA, GMED), in partnership with Quality and Regulatory teams

Support patent and intellectual property (IP) portfolio management activities

Coordinate and support annual clinical activities, including preparation and updates to the Clinical Evaluation Report (CER) and Adverse Event (AE) reviews

Provide clinical support to customer-facing teams by addressing customer questions or feedback that require a clinical or scientific response

Support post-purchase engagement (PPE) activities, including maintenance of PPE and AE tracking tools as part of annual audit requirements

Provide Adverse Event (AE) training to new team members and ongoing clinical education as needed

Partner with the Quality team to support maintenance and effective use of the electronic Quality Management System (eQMS), including Greenlight Guru

Conduct and facilitate the annual company-wide supplier evaluation process, ensuring documentation and compliance with quality and regulatory standards

Provide product training and onboarding support for new hires, ensuring understanding of clinical, regulatory, and quality requirements

Support internal cross-functional collaboration by ensuring teams remain informed of relevant clinical and regulatory considerations

Qualification

Regulatory AffairsClinical AffairsU.S. FDA regulationsElectronic Quality Management SystemsAdverse Event reportingStakeholder managementHands-on responsibilitiesProduct trainingClinical documentationCommunication skillsOrganizational skillsCross-functional collaboration

Required

Bachelor's degree in life sciences, healthcare, regulatory affairs, or a related field; advanced degree preferred

5–8+ years of experience in Regulatory Affairs, Clinical Affairs, or a combined RA/CA role within a regulated medical device or healthcare environment

Working knowledge of U.S. FDA medical device regulations and international regulatory frameworks, including EU MDR and Health Canada

Experience supporting regulatory audits, adverse event reporting, clinical documentation, and post-market surveillance activities

Strong organizational, communication, and stakeholder management skills, with the ability to operate effectively in a cross-functional environment

Comfortable working in a small to mid-sized organization with hands-on responsibilities across multiple functional areas

Preferred

Familiarity with electronic Quality Management Systems (e.g., Greenlight Guru)

Familiarity with several of the following regulations and standards: ISO 14155 (Clinical Investigations), EU MDR 2017/745, MEDDEV 2.7/1 rev. 4 (Clinical Evaluation), U.S. FDA regulations (21 CFR Parts 807, 814, and 820), ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management)

Regulatory Affairs Certification (RAC – Medical Devices), issued by the Regulatory Affairs Professionals Society (RAPS)

Certified Medical Device Auditor (CMDA), issued by the American Society for Quality (ASQ)