Regulatory and Clinical Affairs ManagerPrimary Responsibilities:Regulatory Affairs• Preparation and execution of regulatory submissions, including FDA 510(k) submissions, softwaremodifications, 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 internationalregulatory 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, investigatordocumentation, study reports, and publications.• Coordinate collaborations with hospitals, physician investigators, and academic researchpartners, and assist in organizing collaboration activities.• Work closely with investigators and research coordinators to facilitate study execution, datacollection, and project tracking.• Support development of clinical evidence for regulatory submissions, publications, and productvalidation.• Partner closely with engineering teams to ensure regulatory requirements are incorporatedthroughout product development.• Collaborate with product management, marketing, clinical, and quality teams to supportsuccessful product commercialization.• Independently manage multiple regulatory and clinical projects while maintaining schedules anddeliverables.Qualifications:• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, orrelated 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 researchcollaborations.• 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, medicalimaging, 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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