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3.3 | Cambridge, MA | Hospital & Health Care | 10000+ Employees
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Posted a month ago on Sept. 22, 2020

Sr. Regulatory Affairs Manager

Full-time in Bothell, WA
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Paid Time Off
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Flexible Work Hours
Ability to Telecommute
Wellness Initiatives
Philips is a hospital & health care company headquartered in the Cambridge, MA area with 10000+ employees. Philips has a 3.3-star InHerSight Score, based on 1,197 ratings from 83 employees. Employees have left 23 comments about their experiences working for the company on InHerSight.

Job Title

Sr. Regulatory Affairs Manager

Job Description

In this role, you have the opportunity to

Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submission. 

You will manage a team of regulatory subject matter experts supporting various new and sustaining programs. In this role, including managing the team, you will also be responsible for providing needed direct support to business critical New Product Introduction projects and maintaining lifecycle of regulatory processes that are relevant to meet state of the art requirements.

You are responsible for

  • Leading the team of regulatory professionals responsible for establishing and executing innovative regulatory strategies for New and Sustaining Philips portfolio;
  • Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained;
  • Reviewing and recommending changes for design control processes and manufacturing procedures to maintain quality and regulatory compliance;
  • Providing guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall Philips business priorities globally;
  • Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements are determined to go into effect;
  • Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols;
  • Advising on regulatory policy (for market release) in line with Philips regulatory policy;
  • Where applicable, represent Philips in an international committee chartered to develop an applicable standard;
  • Representing Philips Regulatory Organization in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body;
  • Manage, mentor and coach Philips regulatory professionals in their development;

You are a part of

You are a part of Philips Regulatory Affairs Organization with a global footprint. The Regulatory Affairs team is multicultural and are enthusiastic professionals that work as a team to ensure regulatory compliance.

To succeed in this role, you should have the following skills and experience

  • Bachelor/Master of Science degree in a technical or business discipline;
  • Minimum of 8-10 years of experience in a medical device company;
  • Management experience is required;
  • First line experience with US FDA, China NMPA and EU MDD/MDR is required;
  • Understands the requirements surrounding EU MDR requirements;
  • Maintains detailed knowledge on the subject of ISO 13485 and QSR requirements;
  • Experiences surrounding international regulatory submissions and registrations is required;
  • Must have experience with successful preparation and submission of Technical Documentation, 510(k), PMA, and registrations of medical devices globally;
  • Experience with Software as Medical Devices, and Ultrasound Imaging Devices is preferred;
  • Team player who can work in a matrixed environment with teams in different locations;
  • 5-10% of travel may be required;

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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



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