Regulatory & Clinical Affairs Manager

Role: Regulatory & Clinical Affairs Manager

Locations : Princeton, NJ (Onsite)

(Full Time /Permanent)

Note* FULLTIME Role and This role is on-site at Princeton, NJ

The Role

The Regulatory & Clinical Affairs Manager will play a key role in supporting the Company s regulatory and clinical initiatives across product development, regulatory submissions, and hospital collaborations.

This position is intended for a motivated professional seeking to grow into increasing levels of responsibility within a dynamic medical device environment. The successful candidate will be expected to independently manage assigned projects and develop well-reasoned regulatory recommendations, while working closely with cross-functional teams on overall regulatory and clinical strategy.

This role offers significant opportunities for professional growth, increased ownership, and direct exposure to executive-level strategic planning, regulatory agency interactions, and clinical partnerships.

The position combines regulatory affairs, clinical affairs, and hospital collaboration activities, supporting innovative AI-enabled medical imaging, surgical planning, surgical navigation, and digital health technologies.

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.

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