Philips Senior Regulatory Affairs Engineer in Andover, Massachusetts

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In this role, you have the opportunity to

Provide regulatory leadership for Philips products coordinating and preparing of document packages for regulatory submissions and delivering on competitive regulatory strategies. Working directly with regulatory agencies to achieve best possible outcomes for effective product market clearances you are responsible for the

You are responsible for

  • Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field)

  • Review development quality reports and plans to ensure that the information required for submissions is adequate

  • Plan, generate, and coordinate regulatory submissions for product/solution licensing

  • Coordinate testing required to support regulatory submissions

  • Review and approve product/solution labeling and product/solution-related marketing communications (generally at BIU and field)

  • Maintain existing regulatory filings/ licenses, managing updates and related change control processes (generally at the BIU and field level)

  • Responsible for implementing global regulatory and road maps through understanding the competitive market landscape and product marketing strategy

  • Advises product design teams on regulatory strategy and requirements for specific new products/solutions

  • Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance

  • Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations such as CE Marking and clinical evaluations. Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions

  • Reviews and validates marketing and labeling materials

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

  • Engineering degree or comparable educational background

  • 5+ years of experience in Quality & Regulatory Affairs including Regulatory approval experience

  • Demonstrated project management skills

  • Familiar with International Regulations, Standards and Quality System requirements

  • Ability to multi-task and take firm positions on technical issues when necessary to ensure compliance is maintained

  • Medical Product knowledge preferable

  • Demonstrated project management skills preferable

  • Strong English written and oral communications skills

  • Experience within a process oriented working environment

  • High reliability and quality focus

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

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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