The Regulatory Affairs Specialist provides regulatory leadership for a product line and is responsible to build and deliver on competitive regulatory strategies. The 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
Is the Regulatory Affairs representative for BG and assists 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
Is directly responsible for 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.
Responsible for supporting compliance with EU MDR activities including updating the Technical Files.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree in a technical / healthcare / business discipline or equivalent.
Minimum of 3-5 years of experience in the medical device industry and technical environment with at least 5 years in an Imaging Diagnostic medical device company (FDA Class II equivalent – Class III a plus).
Must have experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide
Strong background in Design Controls.
Excellent working knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations.
Experience in supporting international registrations and clinical investigations
Excellent English skills (written and oral).
Approx. 20% travel annually with some international.
Certified regulatory affairs professional would be desirable.
Background in EU MDR would be desirable
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 https://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 at https://youtu.be/ocnMFp1JBuM .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at https://www.careers.philips.com/professional/global/en/workingatphilips on our career website, where you can read stories from our employee blog at https://www.careers.philips.com/global/en/blog-unexpected . Once there,you can also learn about our recruitment process at https://www.careers.philips.com/global/en/recruitmentprocess , or find answers to some of the frequently asked questions at https://www.careers.philips.com/global/en/faq .