About this opportunity
Healthcare Recruiters International lists this Regulatory and Clincial Affairs Manager opportunity in princeton, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Worksite address
princeton, NJ, 08543, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.