In this role, you have the opportunity to
Lead global regulatory strategy planning for new product introductions and product changes, provide guidance on risk assessment, and required corrective actions to meet regulatory requirements.
You are responsible for
Provide leadership and project management for projects as directed by manager.
Will be the SPC (single point of contact) within the connected sensing regulatory function.
Involved in developing, modifying and executing company regulatory policies that affect immediate operations.
May interact with senior management on matters concerning several functional areas and/or customers.
Facilitate communication and leveraging of best practices within the MA & TC BG and beyond as applicable.
Audit support and follow-up
Facilitate updates to medical device license renewals and establishment registrations
Provide technical competency and guidance to the business group regarding:
Write/submit all 510K applications. Work with BG for review prior to submission.
Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance
To succeed in this role, you should have the following 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.
RAPs RAC preferred. ASQ certifications also desirable.
Must have at least 8 years of experience in the medical device industry (EU MDD, Health Canada, China, US FDA class II and/or class III, etc.).
Direct and current authorship of 510(K) submissions within the past four years. PMA experience is a plus but not required.
Strong background in Design Controls.
Familiarity of medical device regulations (21CFR), FDA law, EU MDR, other global laws, regulations and standards including ISO 14971, IEC 60601-1 and related particular standards.
Understand LEAN concepts, methodologies and deployment.
May require 10% travel annually with possibly some international.
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.