Post Market Surveillance Specialist

Overview

Philips is seeking a Post Market Surveillance (PMS) Specialist to ensure standard PMS and risk management processes across business units for medical devices.

What you'll do

• Ensure standard PMS processes across business units.
• Assure consistent PMS plans exist for all products.
• Assure a consistent, standard process exists for proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions).
• Assure consistent PMS reports across business units.
• In collaboration with Medical Affairs, monitor and assess safety signals, and recommend actions.
• Assess product relationship to reported complaints.
• Assure standard regulatory reporting assessment criteria.
• Provide input to clinical conclusions included in reports to competent authorities.
• Support standard risk management (RM) processes.
• In collaboration with stakeholders, define standard risk acceptability criteria (RAC).
• Support the development of consistent RM plans for all products.
• Assure consistent RM plans exist for all products.
• Provide oversight and clinical guidance on risk assessments, including post-market risk assessments and health hazard evaluations.
• Assure standard PMS and RM governance across business units and provide oversight of PMS and RM processes.
• Ensure standard statistical trending techniques.
• Assess significant triggers and safety concerns.
• Manage recurrent PMS/RM data review meetings.
• Assure a standard approach for signal disposition.
• Incorporate findings in PMS reports and updated RM files as required.
• Represent PMS interests in multi-disciplinary teams during product development.
• Assure development and completion of PMS and RM deliverables throughout the design process.
• Provide input on PMS-related product risk and quality issues during the development of new products.

What you'll need

• Bachelor's degree in engineering or equivalent.
• 8 to 10 years of experience in the medical device industry.
• PMS experience in the Medtech industry (mandatory).
• Adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers, including regulatory bodies.
• English proficiency, oral and written (must have).

Nice to have

• 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 (21CFR 803, 806, 82, etc.), CMDR, JPAL, Medical Devices Directive (93/42/EEC, 98/79/EC), and EU MDR.
• Experience interacting with the FDA, ISO, and other regulatory authorities.
• Excellent communication and analytical skills.
• Project management skills.
• In-depth knowledge of medical terminology.
• Understanding of statistical fundamentals.
• Experience with health hazard evaluations.

Details

• Location: Bangalore.
• Office-based teams work in person at least 3 days per week.