Medical Affairs Manager
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Medical Affairs Manager at PolyNovo advancing patient safety and regulatory compliance. Analyzing safety data and leading cross-functional teams in a highly regulated environment.
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.
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
Similar Jobs
ELO ECM Specialist, Projektmanager
ELO ECM Specialist managing the ELO ECM platform and driving digital transformation initiatives at Th. Geyer GmbH. Responsible for system administration, project management, and cross-functional collaboration.
Manager, Martech
Manager, Martech improving acquisition systems at Mercer Advisors. Focused on Salesforce, automation, and growth tech operations.
Country Manager
Country Manager driving growth across Sweden, Finland, and Denmark for an international iGaming group. Focused on poker ecosystems and emerging market environments with emphasis on commercial strategy.
Senior Manager, Data & Analytics
Senior leadership role managing Data Platform, Governance, and Architecture teams at Blip Global. Driving development and evolution of data systems while ensuring compliance and security.
Senior Manager, Asset Protection
Senior Manager, Asset Protection at Arc’teryx managing risk and loss mitigation to support North America Retail operations. Leading best practices and crisis response frameworks for physical risk incidents.
Field Onboarding & Integration Manager
Field Onboarding & Integration Manager at Thrivent leading onboarding specialists and enhancing advisor launch experiences. Managing training processes and team performance in financial services with a focus on continuous improvement.
Embedded ABM Manager
Embedded ABM Manager executing account-specific marketing plans and strategies. Building engagement with stakeholders to drive Neara's innovative solutions in the energy sector.
Clinical Applications Manager, MR
Clinical Applications Manager overseeing MRI clinical activities, managing scanner protocols and driving productivity at Akumin's fixed sites. Supporting technologists and radiologists with QA/QC programs and training.
Senior Engagement Manager
Senior Engagement Manager driving client success and managing strategic engagements for Seismic's enterprise clients. Focus on building relationships and overseeing implementation of services.
Pre-Access Manager
Manager of Pre-Access overseeing the Patient Access department at Ensemble. Leading improvement initiatives for customer service and departmental performance.
Valuation Manager
Valuation Manager coordinating exchanges between external appraisers and internal departments. Managing the real estate evaluation process with emphasis on quality and stakeholder communication.
Regional Field Manager – North-East
Regional Field Manager leading a team of Area Sales Managers for Vivaris and Berentzen. Focused on sales effectiveness and KPI achievement within the North-East territory of Germany.
Senior Manager, Client Account Support
Senior Manager overseeing client implementations for Under 500 clients at Cigna Healthcare. Driving strategy execution and fostering high-performance teams within the organization.
Engagement Manager
Engagement Manager managing multiple Workday implementations in various sectors. Guiding clients to maximize value from Workday's cloud solutions with a focus on project management.
Senior Manager, Real Estate
Senior Manager of Real Estate managing a portfolio of over 200 globally owned/lease sites for Regal Rexnord. Collaborating with leadership to execute strategies and manage real estate transactions.
Senior Internal Audit Manager
Internal Audit Senior Manager executing audit plans and ensuring compliance in a dynamic banking service environment. Collaborating with teams to shape audit strategies and mentor staff in financial services.
Senior Paid Acquisition Manager
Senior Marketing Specialist managing paid acquisition strategies for ShareGate growth and experimentation with performance marketing channels.
Emergency Response Manager – Stormwater
Stormwater Response Manager handling stormwater-related requests and coordinating resources for national clients. Seeking qualified candidates with project management experience in environmental consulting.
Assistant Stormwater Response Manager
Assistant Stormwater Response Manager handling stormwater-related requests for national commercial clients. Collaborating with internal and external resources to resolve stormwater issues efficiently.
Technical Solution Manager
Technical Solution Manager for Vaisala's Weather, Energy, and Environment team providing specialized technical sales support. Collaborating with diverse teams and contributing to AI-driven efficiency.