Post Market Surveillance, Corrections & Removals Manager (U.S. hub based, EST or CT time zone)The Post Market Surveillance, Corrections & Removals Manager monitors and coordinates Correction & Removal programs for medical or consumer products and includes activities such as preparation of required documentation (e.g. Health Hazard Evaluation, Field Strategy, Field Safety Communications, Regulatory Monitoring Reports, and Termination Requests.) as well as post market surveillance related activities all within the Enterprise Informatics business unit.Your role:
Providing oversight of the corrections and removal process for designated business group to assure Philips addresses product quality issues that may result in a field action; Assuring standard processes and procedures exists across business units under designated business groups; Overseeing the development of FCO documents and Health Hazard Evaluations (HHE) and ensuring proper documentation and alignment.
Collaborating with leadership within Quality and Medical Affairs on the development and approval of the Field Action decision; Providing oversight of the execution of product recalls, and Field Safety Corrective Action Notices with Customers, Dealers, and regional regulatory representatives; Communicating with the FDA and other regulators regarding field actions, as needed; Leading the corrections and removal process for the designated business units under the Enterprise Informatics cluster.
Assessing business performance, capability, and capacity, analyzing business processes, evaluating gaps, identifying process improvements, and developing and implementing business solutions related to correction and removal processes; Collaborating with leaders across Business Units, Markets, and functions to ensure procedures and processes are compliant to all applicable regulations.
Representing Enterprise Informatics in corporate initiatives related to Corrections & Removals, assessing business group impact, developing implementation strategies, and leading implementation; Providing oversight of the execution of Product Recalls and Field Safety Corrective Action Notices with Customers, Dealers, and regional regulatory representatives; Communication with the FDA and other regulators regarding field actions, as needed.
Up to 25% travel required (mostly international).
You're the right fit if:
You’ve acquired 7+ years of related experience in Correction & Removal processes, regulatory submissions, Risk Management, and/or project management preferred within the medical device or similar industry; An ideal candidate will come from a direct correction and removal role within the medical device industry having worked with software. Experience with complaint handling in the medical device industry required. Prior experience working within a global organization/team required.
Your skills include in depth knowledge of relevant quality standards and quality management systems (21 CFR parts 803, 806, and 820, EU MDR- Regulation (EU) 2017/745, ISO 13485, ISO 14971, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169). Project management experience is preferred, as well as supervisory/leadership experience.
You have a master’s degree (preferred) in a relevant field, or an equivalent combination of education and experience.
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 have strong analytical skills, strong communication skills in English (written and oral) with an ability to communicate with various stakeholders, ability to balance and multitask multiple projects/tasks, and high degree of initiative, self-motivation, and flexibility to adapt to an everchanging environment.
About PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we will not 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 the posted location .It 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
