The Sr. Regulatory Affairs Specialist provides regulatory leadership for BG Ultrasound product lines 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.
Is the Regulatory Affairs representative for BG Ultrasound 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.
Skills & Experience you bring to the role:
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.
You are a part of
In today’s challenging and changing healthcare environment, clinicians need every image to contribute to a confident diagnosis and every moment to matter in the clinical workflow.
Philips imaging ultrasound machines bring innovative solutions to clinical complexity while simplifying workflow. Our suite of Ultrasound systems Philips Healthcare Ultrasound is designed to meet the many unique challenges – you can make a difference in your new role every day.
In return, we offer you
We offer you the opportunity to grow within the organization and Philips – working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people’s lives every day.
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 . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more about the testing process Ultrasound
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
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