Sr. Regulatory Affairs Specialist

    • Cambridge, MA

Job Title

Sr. Regulatory Affairs Specialist

Job Description

In this role, you have the opportunity to
provide timely and valued regulatory guidance (written and / or verbal) for multiple sustaining and new product development teams

You are responsible for

  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
  • Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
  • Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
  • Review and approve advertising, promotional items and labeling for regulatory compliance.
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • Communicate application progress to internal stakeholders
  • Collaborate with worldwide colleagues regarding license renewals and updates
  • Maintain regulatory files and tracking databases as required
  • Communicate with regulatory agencies as needed
  • Support the site audit for the responsible products, including NB surveillance audit, FDA inspection, MDSAP audit, and all kinds of unannounced audits etc
  • Provide audit, CAPA and post market regulatory support

To succeed in this role, you should have the following skills and experience
  • Bachelor's degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
  • Minimum 8 years of regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.)
  • Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
  • Proficient knowledge of domestic and international standards
  • Experience with FDA 510(k) submissions
  • RAPs RAC strongly preferred
  • Understand LEAN concepts, methodologies and deployment
  • May require 5% travel annually with possibly some international

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 age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.

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.

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Contact

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