Corrections & Removal Specialist (Post Market Surveillance for Medical Device)

3 weeks ago

Cambridge, Massachusetts, United States Philips Full time
Job TitleCorrections & Removal Specialist (Post Market Surveillance for Medical Device)Job Description

Corrections & Removal Specialist (Post Market Surveillance)

As a Corrections & Removal Specialist your responsibilities will include managing PMS Activities: Leading Correction & Removal (C&R) programs for medical products which includes activities such as preparation of required documentation (e.g. Health Hazard Evaluation, Field Strategy, Field Safety Communications, Regulatory Monitoring Reports, and Termination Requests) related activities for Enterprise Informatics business.

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.
  • Manage business activities related to product quality, efficacy, compliance, and safety issues end to end while collaborating with design, 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 timelines. Provide 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. Responsible for consistent PMS documentation such as PMS plans and RM plans exist for all products
  • 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 6+ 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 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.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. Ability to travel up to 25%.

Additional Information

  • US 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(s).

Philips Transparency Details

The pay range for this position is $104,000 to $178,000, 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.

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.

About Philips

We 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.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Read more about our 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.

#LI-PH1

#LI-Hybrid

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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