Expert Regulatory Specialist
In this role, you have the opportunity to
- Provide expert regulatory support for Image Guided Therapy and execute PMAs for implantable devices in the US, EU MDR transition.
- Be recognized as a Regulatory Expert in US, EU, and other regional Regulatory filings.
- Be considered a vital regulatory point person in multiple scientific and/or technical disciplines, e.g. biocompatibility, mechanical testing, preclinical testing, risk management, CMC etc. , or within a segment (eg CV, PV, LM, Combo)
- Be trusted by Regulatory Affairs (RA) leadership as an independent regulatory expert on strategy and issue resolution
You are responsible for
- Preparing comprehensive regulatory strategies for complex new devices and significant post market changes (e.g. product overhaul/refresh, significant line extension, expanded indications).
- Clearly communicates strategies to RA management, core teams, and business unit leadership Preparing global regulatory filings for new products, as well as post-market changes.
- As necessary, reviews complex regulatory issues with RA manager.
- Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
- Able to professionally negotiate and lead meeting (Pre-Subs) directly with government entities ( FDA, Notified Bodies, etc.) on regulatory filings at the reviewer or management (Chief or Deputy) level.
- All significant issues are negotiated with RA Management. Following Philips Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and all other applicable regulations.
- Maintaining proficiency in worldwide regulatory requirements.
- Develop general strategies on more effective interactions with government agencies and agency personnel.
- Assisting the RA manager with training and direction of regulatory affairs.
You are a part of
As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear collaboration with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- 10+ years regulatory experience (each) in:
- Medical devices
- Original PMA approval
- System integrations
- And preferable implantable and peripheral
vascular therapeutic devices.
- BS degree in a relevant field. BS/MS/PhD in engineering or science preferred
- 10+years of medical device experience with BS degree, and work experience in
regulatory affairs, or 8+ years of medical device experience with MS degree,
and work experience in regulatory affairs, or 6+ years of medical device
experience with PhD, and work experience in regulatory affairs.
- Demonstrated experience in major regulatory filings, e.g. Original PMA, IDE, Design Dossier.
- Must have a working knowledge of FDA, ISO, QSR, and EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions Knowledge of PC hardware/software, documentation and archives.
- Excellent oral and written communication skills.
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
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.
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
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.
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