Global Post Market Surveillance Clinical Expert

Global Post Market Surveillance Clinical Expert (U.S. Hub Based)The Global Post Market Surveillance Clinical Expert will have significant visibility and a chance to make a real difference to our employee and our customers as we add value through post market insights. You will use your clinical experience and expertise to assess events describing significant injury and death allegations at Philips to ensure causal relationship based medical judgment is used to inform business decisions. Additionally, your medical expertise will be used to develop processes and contribute to activities such as adverse event reporting, Issue Impact Assessments (IIA), responses to regulatory inquiries, and Risk Management, ensuring timely assessment and escalation of issues with the potential for patient harm.Your role:

Accountable for preliminary clinical assessments for issues alleging significant injury or death for Philips products as well as providing input for Issue Impact Assessments (IIA); Responsible for contributing to team, department and/or business results, including recruiting, developing, and coaching of talent; Typically influences work of cross-functional or extended business partners.

Participate in Executive Correction and Removals Governance Board meetings and provide clinical insights to support consistent decisions making across Philips; Being part of the PMS Operations team, continuously evaluate effectiveness of overall post market processes to resolve gaps or areas for improvements and solutions to mitigate.

Partner with global complaint handling and correction and removals teams to support improvements in Philips and business level processes to enable efficient and effective execution.

Collaborate with businesses, markets, function, and suppliers to communicate PMS clinical insights in support for driving continuous improvement initiatives for complaint handling and corrections and removals for Philips products.

Drive compliance to global regulations and standards, ensuring operations activities are in accordance to requirements of external governing authorities, internal Quality Management System (QMS), and Philips business process methodologies; Implement and improve the standard way of operating for Philips PMS clinical input to ensure that respective processes are timely, effective, and efficient.

You're the right fit if:

You’ve acquired experience with direct involvement in activities such as Health Hazard Evaluation (HHE), corrections and removals, complaint handling, adverse event reporting, regulatory inquiry response, and/or risk management documentation required; Experience with FDA and/or other regulatory audits/inspections is preferred. Post market experience preferred. Proven experience driving key initiatives or processes in a global, matrixed organization. Experience with leading organizational change is preferred.

Your skills include knowledge of regulations relative to corrections and removals, complaint handling and reporting, and risk management preferred ((ISO 9001/13485/14971, FDA regulations 21 CFR Parts 803, 806, 820, CMDR, JPAL, Medical Devices Directive (93/42/EC, and EU MDR)).

You have a bachelor’s degree or higher in science with a preference towards healthcare or medical profession preferred (e.g. nurse, nurse practitioner, physician assistant, etc.); Licensed or certified healthcare professional with patient care experience preferred. Process excellence or green belt six sigma is preferred.

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) position.

You possess a strong customer focus with doing it right the first-time approach and able to demonstrate high performance behavior of shared accountability. You can drive decision-making while effectively communicating detailed information and strategic decisions to project team members of all levels.

About PhilipsWe 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 improve the lives of others.

Learn more about our business (https://www.philips.com/a-w/about.html) .

Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)

Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)

Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .

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 commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency DetailsThe pay range for this position is $96,850 to $200,256, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here (https://www.careers.philips.com/na/en/best-employee-benefits) .At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted location .#LI-PH1It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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.Equal Employment and Opportunity Employer/Disabled/Veteran