Merit Medical Systems
Senior Manager, Post Market Surveillance
Minnesota - Virtual, USA · Senior
Sponsorship not specifiedDetected 5 days ago
Process ImprovementFDA RegulatoryPharmacovigilanceMedical DevicesResearchLeadershipCommunicationCollaborationProblem SolvingMentoringRegulatory Affairs
About the role
- Work Shift: DAY Work Schedule: Why Merit?
- Attention to detail without losing site of the big picture.
Responsibilities
- Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment.
- Manages and supervises all post market surveillance personnel including interviewing, hiring, training, evaluating performance, coaching and disciplinary actions
- Develops, implements, and measures key performance metrics directly associated with effective operational execution of assigned responsibilities
- Maintains PMS and FCA reporting compliance to all applicable regulation time requirements.
- Maintains appropriate records for PMS, HHE and FCA reporting systems as defined in relevant procedures.
- Establishes and maintains awareness of relevant regulations and standards to ensure the company's post-market surveillance practices align with industry requirements.
- Drives continuous improvement initiatives based on post-market surveillance findings, contributing to product enhancements and risk mitigation strategies.
Requirements
- Knowledge of ISO 14971 Risk Management related activities and requirements.
- Demonstrated experience with electronic data management systems (e.g., Pilgrim, Oracle), computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
- Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and workflows.
- Performs other duties, as required.
Nice to have
- Post graduate diploma / master's degree in quality management.
- Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.
- Strong preference for a proven track record of leadership experience in the development of a large, international team, in multiple regions.
- American Society for Quality (ASQ) Certifications - Certified Quality Engineer (CQE) and/or Certified Biomedical Auditor (CBA)
- Regulatory Affairs Certification - RAC (Global).
- Leadership and coaching.
- Oral and written communication
- Interpersonal skills
Benefits
- Health Hazard Evaluation (HHE) Processes
- Maintains Post Market Surveillance Documentation, Health Hazard Evaluation and Field Corrective Action and Recall systems focused on specific reporting timeliness and consistent, compliant process execution.
Company info
- Together, we are making a difference in the lives of patients around the world.
- Authors timely, responsive, and evidenced based communication to regulatory authorities, notified bodies, customers, and external entities upon request.
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This listing is sourced directly from Merit Medical Systems's careers page and normalized into a canonical job model.