Regulatory Affairs Specialist 3

Job Title

Regulatory Affairs Specialist 3

Job Description

Your Role
In this role you have the ability to prepare and coordinate the documentation packages for regulatory submissions (FDA, Health Canada, EU Competent Authorities, CFDA, ANVISA, etc..) and to recommend strategies for clinical studies and evaluations.

You are responsible for

  • The Regulatory Affairs specialist will 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 and strategies for most efficient and effective approvals of regulatory applications for the business.
  • Supports the cross functional teams with regulatory guidance during all design control phases of a new product or major changes
  • 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.
  • Is directly responsible for the coordination and preparation of document packages for regulatory submissions to the US, EU and Canada [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, US Device Listings, GUDID (UDI), Technical Files, Declarations of Conformity, Medical Device Licenses] for all manufacturing sites.
  • Provides guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X & ISO 14155, Canada Medical Device Regulations, etc.
  • 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.
  • Providing audit and CAPA support.

Skills & Experience you bring to the role:
  • Bachelor's degree (Master's preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
  • 3 plus years of relevant experience in a medical device company (FDA Class I or II equivalent - Class III a plus).
  • 3 plus years of experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide.
  • Strong working knowledge of medical device regulations (21CFR) and FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
  • 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.
  • 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.
  • Excellent English skills (written and oral).
  • May require 5% travel annually with possibly some international.


Desired Qualifications:
  • Certified regulatory affairs professional would be desirable.
  • Background in Software as Medical Devices a Plus
  • Experienced in design control process.

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.

#LI-PH1

Contact

If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. In case of technical difficulties, please send an email to careersite@philips.com .
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)


Meet Some of Philips's Employees

Ankita G.

Software Engineer—Cambridge, MA

Ankita works with the Innovation Group to develop software which assists Philips customers, improving the day-to-day workflows of clinicians so that they can concentrate on their patients.

Dee S.

Service Designer—Cambridge, MA

Dee seeks to understand what Philips’ users are looking for in order to incorporate that information into forward-thinking design solutions that successfully serve customer needs.


Back to top