In this role, you have the opportunity to
Senior Regulatory Affairs Specialist provides regulatory leadership for BG Ultrasound product lines and is responsible to build and deliver on competitive regulatory strategies. Regulatory Affairs Specialist works directly with regulatory agencies to achieve best possible outcomes for effective product market clearances. He / She is responsible for the coordination and preparation of document 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
Assisting with regulatory issues related to such items as labeling and marketing ideas, prepares documents required in the Development Life Cycle, and recommends 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.
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.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree in a technical / healthcare / business discipline or equivalent.
5 plus years of relevant experience in a medical device company (FDA Class I or II equivalent – Class III a plus).
5 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. Excellent English skills (written and oral).
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 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.
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.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 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.