Medical Affairs Manager
PolyNovo Limited
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $150,000 - $160,000 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data analysisrisk managementcomplaint handlingpost-market surveillanceregulatory submissionsbenefit-risk assessmentssafety evaluationspolicy developmenttraining program developmentclinical research
Soft skills
communication skillsinterpersonal skillsstrategic thinkingorganizational skillsproject managementability to engage stakeholdersability to prioritizeability to meet deadlinesbusiness acumenpresentation skills
Certifications
MDDOPhDMSPA-CRN