Regulatory & Clinical Affairs Manager

Regulatory & Clinical Affairs Manager

Location: Darien, CT (On-Site)
Department: Operations
Reports To: SVP, Operations

Salary Range: $90,000 - $120,000

About CEFALY Technology

Founded in 2008, CEFALY Technology is transforming migraine care with innovative, drug-free, and non-invasive therapeutic solutions. Our mission is to solve the persistent problem of migraine through advanced neuro-therapeutic technology.

Our flagship device, the CEFALY DUAL, is an external Trigeminal Nerve Stimulator (eTNS) that delivers controlled electrical impulses through a self-adhesive electrode placed on the forehead to stimulate the trigeminal nerve—helping reduce the frequency and intensity of migraine attacks.

In 2020, CEFALY DUAL became the first device of its kind available over-the-counter (OTC) in the United States. To date, CEFALY has helped treat over 2 billion migraines worldwide, and we continue to expand access to safe, effective, drug-free migraine care.

Position Summary

The Regulatory & Clinical Affairs Manager is responsible for overseeing regulatory compliance and clinical affairs activities across the product lifecycle. This role serves as a key liaison between internal leadership, clinical consultants, quality, and external regulatory authorities, ensuring that clinical, regulatory, and post-market obligations are met in alignment with applicable U.S. and international requirements. The position plays a critical role in supporting audits, adverse event management, clinical documentation, and cross-functional education.

Key Responsibilities

Regulatory & Clinical Affairs

• 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.

Clinical Support & Post-Market 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.

Quality System & Supplier Oversight

• 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.

Training & Internal Enablement

• 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.

Qualifications & Experience

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

Regulatory Knowledge & Standards (Preferred)

• 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)

Certifications (Preferred, Not Required)

• 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)

Compensation & Benefits

• Salary range is $90,000 - $120,000 annually based on experience
• Health insurance (80% employer-paid)
• Employer-paid Dental and Vision
• IRA with company match (no vesting period)
• Paid PTO
• Paid company holidays
• Hybrid