Medical Affairs Manager

Who We Are

At PolyNovo, we are committed to improving the outcomes of patients through the development and provision of the best surgical solutions possible. PolyNovo develops innovative medical devices utilizing the patented bioabsorbable polymer technology NovoSorb. Our lifesaving and life-changing products have revolutionized the treatment of burns and major trauma, and have multiple emerging indications. With 130 employees in the U.S. and over 300 worldwide, PolyNovo has positively impacted the lives of more than 65,000 patients globally.

About The Role

PolyNovo is currently searching for a Medical Affairs Manager to play a pivotal role in advancing patient safety and regulatory compliance. In this position, you will provide expert medical assessment and guidance across Post-Market Surveillance, Quality, R&D, and other cross-functional teams. You will lead investigations into product events, analyze safety data from multiple sources, and translate insights into actionable improvements. Your work will ensure timely, compliant reporting and drive continuous enhancement of product safety and performance.

Key Responsibilities

• 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.

Qualifications

• 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

The salary range for this position is $150,000 - $160,000.

PolyNovo fosters an environment that promotes equity, diversity, and inclusion. We recognize and value that it is the sum of our parts – our combined backgrounds, experiences and perspectives – that allow us to succeed.  PolyNovo is an equal opportunity employer and provides equal employment opportunities to all applicants without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.