Philips Sr Post Market Surveillance & Product Safety Manager 

India, Maharashtra 

750170380

Sr. Post Market Surveillance & Product Safety Manager

Job Description: Sr. Product surveillance and Product Safety Manager

The Senior PMS and Product Safety Manager is responsible for the safety and efficacy of products. Responsibilities include managing PMS activities, complaint Handling & regulatory reporting oversight activities, and review post market and signal assessment data for potential product performance and safety issues.
Serves as a liaison between Medical Affairs, Clinical Affairs, Research & Development, and Complaint Handling to ensure Post Market Surveillance (PMS) and Risk Management (RM) processes are executed end-to-end (E2E).
Investigate and Review complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs. Assists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.
The Senior PMS and Product Safety Manager has relevant medical background and product/ medical device industry experience. He has expertise in all regulations related to FDA Medical Device Reporting, EUMDR, and post market surveillance requirements regulations in other international regions.

You are responsible for

• Manage a team business activities related to product quality, efficacy, compliance, and safety issues end to end.
• Drive signal assessment and escalations, and product performance governance.
• Develops strategical changes needed to assure timely & accurate product performance information is available to enable actionable decisions that drive product designs and improvementsthat delight our customers and assure their safety.
• Collaborate with design and manufacturing and supplier teams to perform root cause analysis on defects, utilizing root cause analysis concepts to investigate issues related to commercialized medical devices in the field and implement Corrective and Preventive Actions including effectiveness checks
• Oversee the Complaint handling activities, ensuring all KPI’s are met including complaint investigations and regulatory reporting timeliness.
• Assesses product relationship to reported complaint and drive effective root cause investigations.
• Provides quality and compliance input and coaching for sustaining supporting groups such as post market sustaining activities, Risk Management activities, and CAPAs among others.
• Ensures standard PMS processes across business units
• Ensures consistent execution of postmarket risk assessments.
• Responsible for consistent PMS documentation such as PMS plans and RM 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
• In collaboration with Medical Affairs, monitors and assesses safety signals, and recommends actions
• Provides input to clinical conclusion to be included in the reports to competent authorities
• Provides expertise in related specific field of knowledge or product in the investigation of commercialized medical devices in the field.
• Track and analyze product defects to identify product and process, improvements.
• Partners with Supplier Quality to facilitate the completion of Supplier Corrective Actions, to ensure timely closure of assigned action in active complaints
• Collaborates with design, risk management and others to ensure the Risk Management files (Hazards Analysis, DFMEA, UFMEA & PFMEA) for assigned product families are maintained and up to date.
• Serves as key partner and liaison between Medical Affairs, Clinical Affairs, Research & Development, and Complaint Handling among others to ensure accurate product performance information is available to enable actionable decisions that drive product designs and improvements that delight our customers.

• REQUIRED Education KNOWLEDGE, SKILLS, ABILITIES andCERTIFICATIONS/LICENSES:
• Bachelor’s or Master’s degree in Engineering, Science, or equivalent technical degree
• 10+ years of experience in the pharmaceutical / medical device industry or direct device clinical experience
• 5+ years’ experience supervising others
• Process improvement capabilities and experience
• Strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers)
• Ability to successfully balance and prioritize multiple ongoing projects/task
• In-depth knowledge of Quality management systems. Proven work experience and knowledge with medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
• Demonstrates collaborative patient and customer focus.
• Experience interacting with the FDA, ISO, and Other Regulatory Authorities.
• English proficiency oral and written must have adequate computer skills.
• Excellent communications and analytical skills.
• In-depth knowledge of medical terminology.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .