Medical Affairs Manager

Job Description: • Assess global complaints and adverse events for medical impact and regulatory reportability, ensuring timely escalation and compliant investigations • Lead medical evaluations of product events, analyze safety data from multiple sources, and identify trends to drive continuous improvement and patient safety • Provide expert guidance on complaint interpretation, regulatory submissions, and risk management to cross-functional teams including PMS, QA, R&D, and Regulatory Affairs • Develop and maintain safety-related policies, procedures, and training programs to foster a culture of compliance and quality • Collaborate on regulatory documentation and benefit-risk assessments (e.g., CERs, SSCPs, PMCF, PSUR) and support audits and inspections with global health authorities • Manage safety-related inquiries from healthcare professionals and internal stakeholders, ensuring accurate and compliant responses • Stay current with evolving regulations and ensure adherence to global standards, including GCP, ICH, EMA, and PolyNovo’s Code of Conduct. Requirements: • Advanced clinical or scientific degree (MD, DO, PhD, MS, PA-C, or RN) with research experience preferred • Minimum 4 years of relevant clinical experience; equivalent education/experience combination considered • Strong communication and interpersonal skills with the ability to engage surgeons and cross-functional teams • Proven ability to analyze complex data, think strategically, and operate effectively in a highly regulated environment • Excellent organizational and project management skills; able to prioritize and meet deadlines • Proficiency in Microsoft Office applications and familiarity with global medical device regulations • Business acumen and ability to present scientific information clearly to diverse audiences • Knowledge of post-market surveillance and complaint handling is highly preferred. Benefits: • Total compensation package consisting of base salary, bonus, and incentive plans • 401k plan with company match • Comprehensive medical, dental, and vision insurance for employees and their families • Generous paid time off, 12 company holidays, and two paid Nurture days per year • Parental leave for primary and secondary caregivers Apply tot his job