The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
United States of America - Home Based, Minnesota, United States
Job Type Full time Job Number 422113
If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
Provide regulatory support to for our Image Guided Therapy business group including our Stellarex drug/device combination products either through direct submission activities or indirect project management of worldwide registrations.
Be recognized as an internal subject matter expert in Regulatory Affairs
Act as an independent regulatory core team lead on project teams.
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 meetings (eg Pre-Subs) directly with government entities (e.g. FDA, Notified Bodies, etc.) on regulatory filings at the reviewer or management (eg 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 of regulatory experience, preferably in one or more of the following areas:
original PMA approval
drug/device combination products
system integrations and
peripheral vascular therapeutic devices.
BS degree in a relevant field. MS or PhD in engineering or science field 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 such as 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. Learn more by watching this video.
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.
Equal Employment and Opportunity Employer/Disabled/Veteran
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