Philips Regulatory Affairs Specialist in Maple Grove, Minnesota
Developing global regulatory strategies
Executing assigned regulatory tasks for device changes and manufacturing processes. Clearly communicates status and completion of assigned tasks to more senior RA management
Support more senior RA specialists in the preparation of regulatory filings for new products, as well as product and manufacturing changes. Reviews regulatory issues with RA management
Preparing documentation for international and U.S. registrations
Following Spectranetics Quality System procedures to ensure compliance with 21CFR820, ISO13485, EU MDD/MDR, CMDR and all other applicable regulations
Developing proficiency in world-wide regulatory requirements
BS or Master’s degree in Engineering or Science, Associates degree with at least 1-2 years of medical device experience.
Sufficient oral communication and technical writing skills
Working knowledge of FDA and international regulations
1-2+ years’ experience with medical device regulatory submissions
Knowledge of PC hardware/software, documentation and archives
In this role, you have the opportunity to develop and implement global regulatory strategies and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy
You are responsible for
Participating in and advising cross-functional new product/solution development teams on applicable regulations, requirements and standards
Reviewing development quality reports and plans to ensure that the information required for submissions is adequate
Planning, generating and coordinating regulatory submissions for product/solution licensing
Coordinating testing required to support regulatory submissions
Maintaining existing regulatory filings/licenses, managing updates and related change control processes
To succeed in this role, you should have the following skills and experience
Bachelor’s degree in a technical discipline
3+ years experience in the medical device industry and technical environment
3+ years experience in an FDA environment (class II equivalent, class III a plus)
Experience with successful preparation and submission of 501(k), PMA or international documents or registration and marketing of medical devices worldwide
Working knowledge of 21 CFR, FDA law, MDD and other global law and regulations
Experience in supporting international registrations and clinical investigations
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 .
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.