Regulatory and Clincial Affairs Manager

Healthcare Recruiters International; Princeton (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Healthcare Recruiters International is seeking a Regulatory and Clinical Affairs Manager in New Jersey. This role oversees regulatory submissions, safety and compliance activities, and clinical study coordination to support product development and regulatory approvals.

You will collaborate with engineering, QA, and clinical teams to ensure alignment with ISO, EU MDR, and FDA requirements, while managing multiple projects and timelines.

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 ISO 13485, ISO 14971, and IEC 62304.
• Experience with SaMD, AI/ML-enabled medical devices, digital health products.
• Experience with EU MDR and Technical Documentation submissions.
• Experience interacting with FDA, notified bodies, and clinical investigators.

Responsibilities

• Prepare regulatory submissions, including FDA 510(k) submissions and international registrations.
• Assess regulatory impact of software, AI/ML, cybersecurity, and product changes.
• Develop regulatory strategies for new products and software upgrades.
• Support interactions with FDA, notified bodies, regulatory consultants, and international agencies.
• Monitor evolving regulatory requirements and communicate impacts.
• Support regulatory assessments related to design changes and clinical evidence.
• Coordinate IRB submissions, clinical study protocols, and investigator documentation.
• Collaborate with hospitals, investigators, and academic partners on research.
• Develop clinical evidence for regulatory submissions, publications, and validation.
• Partner with engineering to ensure regulatory requirements are integrated into development.
• Collaborate with product management, marketing, clinical, and quality teams for commercialization.
• Manage multiple regulatory and clinical projects with schedules and deliverables.

Skills

Regulatory affairs

Clinical studies coordination

Technical writing

Project management

Cross-functional collaboration

Regulatory strategy

Communication skills

Product development liaison

Education

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

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.