Job Title Post Market Surveillance Specialist Job Description Job Title : Post Market Surveillance Specialist Job 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 (21CFR (803, 806, 82, etc.)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), 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 How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. About Philips Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights

Post Market Surveillance Specialist.

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