Senior Manager-Post Market Surveillance

Job Title

Senior Manager-Post Market Surveillance

Job Description

Exciting opportunity to play a critical role in ensuring Philips Hospital Patient Monitoring (HPM) products are safe, reliable and of the highest quality, through leadership of various Post Market Surveillance activities, at all HPM sites globally.

The Sr. Post Market Surveillance Manager is responsible for working with all HPM sites worldwide to oversee various Post Market Surveillance activities, including:

• Hosting timely Field Action Committee (FAC) meetings and ensuring field action documentation (customer letter, 806 report, etc.) is created and maintained.
• Interfacing with the Global Complaint Handling Organization to ensure post market data accuracy and relevance.
• Preparing FDA monthly reports in support of 21CFR 806 field action requirements and provides documents in support of audits as needed.
• Maintaining the "official record" field action file, ensuring all documentation is complete/appropriately filed in accordance with department standards to facilitate easy retrieval for audit support.
• Preparing FDA requests for termination documentation, including any product reconciliation required in the final destruction of affected product.
• Tracking recall activities to closure and prepares the final closure documentation for each field action file.
• Submitting monthly status reports and managing Periodic Safety Update Report (PSUR) updates.
• Participates in post market surveillance/field action data review meetings, compiles field action data in support of BU Management Reviews and ensures data accuracy for metric reporting.
• Participates/supports in the development, revisions, review, issuance and training of Philips policies and procedures related to Post Market Quality and the field action process as needed.
• Reporting to the Head of Quality for Hospital Patient Monitoring, you will work with all sites and Regulatory, Quality, Clinical, Operations, and R&D professionals worldwide to oversee various post market quality activities, as well as Regional Representatives from North America, EMEA, Latin America and Greater Asia to ensure alignment of field action execution.
• This Hybrid, Pittsburgh, PA based role may require travel up to 10%.

You're the right fit if:

• You've acquired a Minimum of 7 years' experience focused on FDA regulated Post Market Surveillance activities in the Medical Device or Pharmaceutical industry, with detailed knowledge of worldwide quality systems requirements, including ISO 13485, FDA/21 CFR 820 and other international standards as required.
• Your skills include proficiency in Microsoft Office, specifically Word and Excel.
• You have a Minimum of a Bachelor's Degree (Required), Master's Degree desired.
• You have the proven ability to work effectively in a global, matrixed organization, across business units, regions, and manufacturing sites.
• You have Strong communication, organization, and prioritization skills.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
• 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 be within commuting distance to Pittsburgh, PA.

About Philips:

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 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.

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