![Philips](https://contents.bebee.com/companies/us/philips/avatar-BNuWf.png)
Corrections & Removal Manager (Post Market Surveillance for Medical Device)
2 months ago
Post Market Surveillance, Corrections & Removals Manager (U.S. hub based, Eastern or Central time zone)
As a Post Market Surveillance Manager 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) as well as post market surveillance (Complaint Handling, PMS Activities) 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 8+ 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 $99,000 to $169,000, 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.
-
Cambridge, Massachusetts, United States Philips Full timeJob TitleCorrections & Removal Specialist (Post Market Surveillance for Medical Device)Job DescriptionCorrections & 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...
-
Research Associate, AMP-Seq
1 month ago
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Senior Scientist, AMP-Seq Team Lead
2 months ago
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Electrical Design Engineer
15 hours ago
Cambridge, Massachusetts, United States Nanobiosym Full timeJob OverviewNanobiosym, a pioneering nanotechnology company based in Cambridge, MA, is seeking a highly skilled Electrical Design Engineer to join our team. As a key member of our engineering department, you will play a crucial role in developing innovative medical devices that address a broad range of diseases.Key ResponsibilitiesDesign and develop...
-
Senior Product Manager, Point of Care
13 hours ago
Cambridge, Massachusetts, United States Philips Full timeAbout the Role:We are seeking a highly skilled Senior Product Manager to oversee the development, launch, and life-cycle management of Ultrasound devices used for a wide range of medical imaging applications within our Point of Care business.Your Key Responsibilities:Manage upstream strategy and execution of products and solutions, including definition of...
-
Director, Safety Risk Management Scientist
2 months ago
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Cambridge, Massachusetts, United States Biogen Full timeJob OverviewBiogen is in search of an experienced Lead Quality Engineer specializing in Combination Products to join our Quality, Combination Products, and Devices team. This pivotal role will involve providing extensive quality oversight throughout the lifecycle of combination products. Your proficiency in design control, risk management, and human factors...
-
Senior Regulatory Project Manager
2 months ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleSenior Regulatory Project ManagerJob DescriptionThe Senior Regulatory Project Manager will play a critical role in ensuring Philips products are safe, reliable, and compliant, through managing critical initiatives focused on the collection, gap identification, impact assessment, gap closure/implementation planning activities and ensuring relevant...
-
Marketing Project Manager
3 weeks ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleMarketing Project Manager - Product Launch (Cambridge)Job DescriptionMarketing Project Manager - Product Launch (Cambridge)Launch new products, services and solutions in the North America Region to bring innovation and productivity enhancements to our customers. Lead multiple projects, work across Philips businesses and partner with Region...
-
Senior HCP Marketing Manager
1 week ago
Cambridge, Massachusetts, United States Biogen Full timePosition OverviewAbout the RoleThe Senior Manager, HCP Marketing for Rare Disease, specifically Friedreich Ataxia (FA), presents a remarkable opportunity to contribute to a developing franchise within a therapeutic area characterized by significant unmet needs. This role is integral to the FA launch marketing team, focusing on the development and execution...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Provide worldwide regulatory strategy and oversight to ensure Moderna can describe, and support processes required for commercialization of INT products (i.e., neoantigen selection (next generation sequencing and bioinformatics) as well as related to front end specimen collection. Provide regulatory strategy and oversight for all Moderna Companion...
-
Digital Marketing Manager
10 hours ago
Cambridge, Massachusetts, United States Philips Full timeAbout the Role:We are seeking a highly skilled Digital Marketing Manager to join our team at Philips. As a Paid Search Media Specialist, you will be responsible for setting up and running successful B2B paid search campaigns on Google and Bing.Your Key Responsibilities:Develop and execute paid search strategies to drive business growth and meet key...
-
Event Marketing Manager
10 hours ago
Cambridge, Massachusetts, United States iAdvize - The Conversational Commerce Platform Full timeAbout iAdvize - The Conversational Commerce PlatformiAdvize is a leading player in the conversational commerce space, helping brands build genuine relationships with shoppers at scale. Our unique platform connects online shoppers to a smart mix of in-store associates, on-demand brand power users, in-house agents, and AI chatbots through 1:1 messaging.Job...
-
Event Marketing Manager
11 hours ago
Cambridge, Massachusetts, United States iAdvize - The Conversational Commerce Platform Full time**Job Summary**iAdvize, the conversational commerce platform, is seeking a skilled Marketing Event Coordinator to join our team. As a key member of our marketing department, you will be responsible for coordinating live commerce events and projects, ensuring seamless execution and exceptional client satisfaction.**Key Responsibilities**• Master the live...
-
Lead Prepared Foods Coordinator
3 days ago
Cambridge, Massachusetts, United States Whole Foods Market Full timeJob Overview The Prepared Foods Team Leader is responsible for providing comprehensive leadership to the Prepared Foods department. This role encompasses all facets of daily operations, including financial performance, cost management, procurement, product presentation, workforce management, compliance with regulations, and special initiatives as...
-
Senior Digital Marketing Strategy Manager
1 month ago
Cambridge, Massachusetts, United States InterSystems Full timeWe are seeking a dynamic Senior Digital Marketing Manager for North America to join our team. The ideal candidate will be responsible for developing and executing digital marketing strategies that drive engagement, creating demand and lead generation within our core technologies and target industries.This position requires collaborating closely with the...
-
Senior Marketing Manager, Campaign Activation
19 hours ago
Cambridge, Massachusetts, United States Philips Full timeAbout the RoleWe are seeking a highly skilled Marketing Campaign Manager to lead the creation of engaging campaigns that capture the essence of our brand expressed in our products.Key ResponsibilitiesDevelop Annual Campaign Activation Calendar: Design and implement a comprehensive campaign activation calendar that aligns with our business objectives.Launch...
-
Services and Install Base Marketing Manager
3 weeks ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleServices and Install Base Marketing Manager (Cambridge)Job DescriptionServices and Install Base Marketing Manager (Cambridge, MA)In this role, you define and shape the way Philips engages Customers in the North American healthcare market.Services provides an incredible marketing opportunity to communicate innovative capabilities to the market, while...
-
Prepared Foods Operations Supervisor
3 days ago
Cambridge, Massachusetts, United States Whole Foods Market Full timeJob Overview The Prepared Foods Team Leader is responsible for providing comprehensive leadership to the Prepared Foods team. This role encompasses all facets of daily operations, including profitability, expense management, procurement, merchandising, labor oversight, regulatory compliance, and special projects as designated. The Team Leader is...
-
Manager, Data-Driven Marketing
21 hours ago
Cambridge, Massachusetts, United States Analytic Recruiting Inc. Full timeJob Description**About the Role**We are seeking a highly skilled Senior Manager, Digital Insights to join our team at Analytic Recruiting Inc. As a key member of our marketing team, you will be responsible for providing data-driven insights to inform business decisions and drive marketing strategies.Key ResponsibilitiesDevelop and implement data-driven...