Post Market Surveillance Specialist

Job Summary

Job Title : Post Market Surveillance Specialist

Responsibilities

Post Market Surveillance (PMS)

• Ensures standard PMS processes across business units
• Assures consistent PMS plans exists for all products
• Assures consistent and standard process exists to perform proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions)
• Assures consistent PMS Reports across business units

Patient Safety and Regulatory Reporting

• In collaboration with Medical Affairs, monitors and assesses safety signals, and recommends actions
• Assesses product relationship to reported complaint.
• Assures standard regulatory reporting assessment criteria
• Provides input to clinical conclusion to be included in the reports to competent authorities

Risk Management

• Support standard RM processes
• In collaboration with stakeholders, defines standard risk acceptability criteria (RAC) with stakeholders
• Supports the development of consistent RM plans exists for all products
• Assures consistent RM plans exists for all products
• Provides oversight and clinical guidance on risk assessments including post-market risk assessments and health hazard evaluations

PMS and RM Governance

• Assures standard PMS and RM governance across Business Units
• Provides oversight of PMS and RM processes and assures standard approach
• Signal Assessment & Escalation:
• Ensures standard statistical trending techniques
• Assesses significant triggers & safety concerns.
• Manage recurrent PMS/RM data review meetings
• Assures standard approach for signal disposition
• Incorporate findings in PMS reports and updated RM files as required

PMS and RM input into Product Development

• Represent PMS interests in multi-disciplinary teams during product development.
• Assures development and completion of PMS & RM deliverables throughout the design process
• Provides input of PMS related product risk & quality issues during the development of new products

Technical Knowledge and Skills required

• Bachelor's degree in engineering or equivalent
• 8 to 10 years of experience in the medical device industry
• PMS experience in Medtech industry - Mandatory

Other Desirable Knowledge, Skills, Abilities and Certifications/Licenses

• Demonstrates collaborative patient and customer focus
• Regulatory Affairs, Quality Assurance, or Complaint Handling experience in pharmaceuticals or medical devices
• Direct experience/knowledge of most regulations relative to PMS activities and reporting, such as: ISO 13485/14971, FDA Regulations (21 CFR (803, 806, 82, etc. )), CMDR, JPAL, Medical Devices Directive (93/42/EEC), and EU MDR is preferred.
• Experience interacting with the FDA, ISO, and Other Regulatory Authorities preferred.
• English proficiency oral and written must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.
• Excellent communications and analytical skills
• Project management skills preferred
• In depth knowledge of medical terminology preferred
• Understanding of statistical fundamentals is preferred
• Experience with health hazard evaluations is preferred

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.