Regulatory and Clincial Affairs Manager

Regulatory and Clinical Affairs Manager

Primary Responsibilities:

• Preparation and execution of regulatory submissions, including FDA 510(k) submissions, software modifications, and international registrations as applicable.
• Assess regulatory impact of software, AI/ML, cybersecurity, and product changes.
• Develop regulatory strategies and recommendations for new products and software upgrades.
• Support interactions with FDA, notified bodies, regulatory consultants, and international regulatory agencies.
• Monitor evolving regulatory requirements and communicate potential impacts to the organization.
• Support regulatory assessments related to design changes, risk management, verification, validation, and clinical evidence.

Clinical Affairs & Hospital Collaboration

• Support preparation and submission of IRB applications, clinical study protocols, investigator documentation, study reports, and publications.
• Coordinate collaborations with hospitals, physician investigators, and academic research partners, and assist in organizing collaboration activities.
• Work closely with investigators and research coordinators to facilitate study execution, data collection, and project tracking.
• Support development of clinical evidence for regulatory submissions, publications, and product validation.
• Partner closely with engineering teams to ensure regulatory requirements are incorporated throughout product development.
• Collaborate with product management, marketing, clinical, and quality teams to support successful product commercialization.
• Independently manage multiple regulatory and clinical projects while maintaining schedules and deliverables.

Qualifications:

• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field.
• 5+ years of experience in medical device regulatory affairs.
• Experience preparing and/or leading FDA 510(k) submissions.
• Experience supporting clinical studies, IRB submissions, or hospital-based research collaborations.
• Strong technical writing, project management, and communication skills.
• Experience working directly with engineering teams during product development.
• Familiarity with medical device quality systems and standards, including ISO 13485, ISO 14971, and IEC 62304.
• Experience with Software as a Medical Device (SaMD), AI/ML-enabled medical devices, medical imaging, surgical navigation, robotics, or digital health products.
• Experience with EU MDR and Technical Documentation submissions.
• Experience interacting with FDA, notified bodies, and clinical investigators.