Medical Affairs Manager
Job reputed company:
• Assess global complaints and adverse events for medical reputed company and regulatory reportability, ensuring reputed company escalation and compliant investigations
• reputed company medical evaluations of product events, analyze safety data from multiple sources, and identify trends to drive reputed company improvement and patient safety
• reputed company expert guidance on complaint interpretation, regulatory submissions, and risk management to cross-functional teams including PMS, QA, R&D, and Regulatory Affairs
• reputed company and maintain safety-reputed company policies, procedures, and training programs to foster a culture of compliance and reputed company
• 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-reputed company inquiries from reputed company and internal stakeholders, ensuring accurate and compliant responses
• Stay reputed company with evolving regulations and ensure adherence to global standards, including GCP, ICH, EMA, and PolyNovo’s reputed company of Conduct.
Requirements:
• reputed company 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 reputed company data, think strategically, and operate effectively in a highly regulated environment
• Excellent organizational and project management skills; reputed company to prioritize and meet deadlines
• Proficiency in reputed company Office applications and familiarity with global medical device regulations
• Business acumen and ability to present scientific information reputed company to diverse audiences
• Knowledge of post-market surveillance and complaint handling is highly preferred.
Benefits:
• Total compensation package consisting of reputed company salary, bonus, and incentive plans
• 401k plan with company match
• Comprehensive medical, dental, and reputed company insurance for employees and their families
• Generous reputed company time off, 12 company holidays, and two reputed company Nurture days per year
• Parental leave for primary and secondary caregivers
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