Senior Regulatory Project Manager

2 months ago

Cambridge, Massachusetts, United States Philips Full time
Job TitleSenior Regulatory Project ManagerJob Description

The 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 QMS updates related to evolving medical devices standards.

Your role:

  • In collaboration with the PMO, Product Leads and Core Team, develop, and Quality, design, implement, and manage technical development plans for all required programs (both pre/post market, this includes budgets, timelines and schedules, resources, business impact analysis, and status report out.
  • Managing the Standard Compliance Programs while remaining current on standards affecting Philips products. Responsible for keeping the relevant team and supervisors informed about potential impact throughout the product's lifecycle. Provides inputs to Regulatory leadership to develop global regulatory compliance strategies. Responsible for the development and implementation of internal business processes and systems used to stay abreast of global standards to help Philips achieve our business goals within the scope of this position.
  • Will manage projects focused on ensuring applicable medical device standards are understood and properly implemented within the Philips QMS. Maintains project data necessary to understand assumptions/progress made, and issues or risks associated with the projects. Organizes the archives of project information. Teaches project stakeholders how to effectively access information to help drive appropriate decisions. Provides technical guidance and training to Philips staff during strategy formulation, submission preparation and development of labeling, marketing, or promotional materials and in training on departmental policies and procedures related to Standards.
  • Supports all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements. Responsible for owning and managing relevant CAPAs related to new and changing Standards implementation and compliance.
  • Reporting to the Director of Regulatory Operations you will collaborate with functional area leaders and internal subject matter experts to lead the optimization of Philips QMS, including the product development and design controls processes to ensure that our customers have access to products maintained at State of the Art. Act as the liaison with aligned Corporate Philips teams and other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for standard compliance initiatives. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

You're the right fit if:

  • You've acquired a minimum of 7 years' experience working in Regulatory Affairs within FDA regulated medical device/technology environments, with detailed knowledge in FDA, ISO, and EU regulations for Regulatory Submissions, complaint handling, reporting incidents, and implementing corrective and preventive actions.
  • You have experience working in a broader enterprise/cross division business unit model (preferred), as well as strong organizational, planning/follow-up skills and ability to hold others accountable.
  • You have proven leadership skills, including goal setting, providing positive/constructive feedback to build positive relationships and improve business results.
  • Your skills include detailed knowledge and expertise in authoring FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), PMA, Technical Files/Design Dossier, etc.).
  • You have a minimum of a Bachelor's Degree (required), Master's degree desired.
  • You have demonstrated experience working in a highly matrixed, geographically diverse business environment and the ability to work effectively within a team in a fast-paced changing environment.
  • You have the ability to communicate, influence and build relationships with Internal/External Stakeholders at all levels.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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 either Cambridge, MA or 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.

#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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