Regulatory Affairs Specialist

Job Title

Regulatory Affairs Specialist

Job Description

In this role, you have the opportunity to develop and implement global regulatory strategies and road-maps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy.

Description:

  • Performs specific regulatory tasks in support of a regulatory filing with oversight from management or more senior regulatory affairs specialists
  • Strong organizational skills and time management skills
  • Ability to multitask, support multiple projects, function on a global basis, prioritize, and meet project deadlines
Responsibilities:
With the supervision from the Regulatory Affairs (RA) Management, a Regulatory Affairs Specialist is responsible for:
  • Support more senior RA specialists in the preparation of global regulatory filings for new products, as well as product and manufacturing changes.
  • Support more senior specialists in the review of engineering change orders
  • Developing regulatory tactics for submissions and registrations.
  • Preparing post-market submissions i.e. PMA annual reports, updating technical files, and international registrations.
  • Reviews regulatory issues with RA management.
  • Developing proficiency in global regulatory requirements.
  • Developing working knowledge of US, EU, International, and Quality System regulatory requirements
  • Developing an understanding of clinical practice of assigned product areas
  • Following Philips/ Spectranetics Quality System procedures to ensure compliance with 21 CFR 820, ISO 13485, MDD, PMDA, CMDR and all other applicable regulations.
Position Requirements:
  • BS degree in a relevant field (BS/MS in engineering or science preferred)
  • 2+ years of medical device experience with BS degree, and work experience in Regulatory, R&D, Quality, Clinical or Manufacturing
  • 0+ years of medical device experience with MS degree
  • Sufficient oral and written communication skills
  • Successfully submitted or participated in the submission of regulatory filings
  • Working knowledge or understanding of FDA, ISO, QSR, and EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions Knowledge of PC hardware/software, documentation and archives

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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