Regulatory Affairs Specialist

Job Title

Regulatory Affairs Specialist

Job Description

In this role you will have the opportunity to meet all of the regulatory needs and actions needed to support the Respiratory Care mask business. The primary task of the Regulatory Affairs Group is to obtain domestic and international regulatory clearances, approvals, registrations and licenses for new and existing medical devices.
You are responsible for

You will be a core member on product development teams, the Regulatory Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks.

  • 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 engineering changes, 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.
  • Provide audit and CAPA support.
  • 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


You are part of

Philips is a diversified technology company, focused on improving people's lives through meaningful innovation. With a century of history and more than 450 innovative products and services, we are ready to meet today's challenges in healthcare by creating solutions that deliver better care to more people at lower cost.

Philips Respironics is a global leader in the sleep and respiratory markets, we're passionate about providing solutions that lead to healthier patients, practices, and businesses. For us, innovation in sleep apnea management, oxygen therapy, noninvasive ventilation, and respiratory drug delivery is driven by gaining insight into the needs of our customers.

Skills and experience

  • Bachelor's degree (Master's preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
  • Experience with ventilators strongly preferred.
  • Minimum of 5 years of experience in the medical device industry (EU MDD/MDR, Health Canada, US FDA class II or class III, etc.).
  • Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
  • Must have personal experience with successful preparation and submission of 510(k) submissions.
  • Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 highly desirable.
  • Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
  • RAPs RAC strongly preferred. ASQ certifications also desirable.
  • 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.
  • Strong background in Design Controls.
  • Experience in supporting international registrations and/or clinical investigations.
  • Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
  • Proficient computer skills in Microsoft Office.
  • Understand LEAN concepts, methodologies and deployment.
  • May require 5% travel annually with possibly some international.


We offer you

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

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. Learn more by watching this video .
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 .

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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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