Regulatory & Clinical Affairs Manager

Regulatory & Clinical Affairs Manager

Princeton, NJ

Permanent

Qualifications:

•              Bachelor’s degree in engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field.

•              5-12 years of experience in medical device regulatory affairs.

•              Hands-on experience on FDA, CE, EU MDR submissions - candidates themselves shall still be active in preparing the submissions, rather than serving only in a managerial or oversight capacity

•              Experience with Software as a Medical Device (SaMD)/SiMD, AI/ML-enabled medical devices, medical imaging, surgical navigation, robotics, or digital health products.

•              Experience preparing and/or leading FDA 510(k) submissions.

•              Experience supporting clinical studies, IRB submissions, or hospital-based research collaborations

•              Familiarity with medical device quality systems and standards, including ISO 13485, ISO 14971, and IEC 62304.

•              Experience with EU MDR and Technical Documentation submissions.

•              Clinical affairs experience is a plnice to have

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.