Regulatory & Clinical Affairs Manager

Role Overview

• 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.

Requirements

• 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.

Benefits

• Health insurance (80% employer-paid)
• Employer-paid Dental and Vision
• IRA with company match (no vesting period)
• Paid PTO
• Paid company holidays