Senior Regulatory Affairs Specialist

In this role, you have the opportunity to

Our Senior Regulatory Affairs Specialist will provide regulatory support to the Regulatory Affairs Department ensuring compliance with applicable US and international regulations in which the company does business; preparing product submission documentation for US and international markets and evaluating product changes for effects on regulatory license registrations.

You are responsible for

• Preparing comprehensive regulatory strategies for new devices and post market changes.
• Clearly communicates strategies to RA management, core teams, and business unit leadership
• Preparing regulatory filings for new products, as well as significant 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 identify risks within regulatory strategies and clearly communicate... risks to projects teams and RA management
• Able to professionally negotiate directly with government entities (e.g. FDA, Notified Bodies, etc.) on regulatory filings at the reviewer level.
• Following Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP and all other applicable regulations.
• Maintaining proficiency in broad, regional regulatory requirements.
• Develop general strategies on more effective interactions with government agencies and agency personnel.
• Assisting the RA Manager with training of more junior specialist staff.

You are a part of

Our solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. ​​ The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology.

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.
• BS degree in a relevant field (BS/MS in engineering or science preferred)
• 5+ years of medical device experience
• Experience authoring 510(k)s
• Considered a key regulatory point person in a scientific or technical discipline, e.g. biocompatibility, mechanical testing, preclinical testing, risk management, CMC etc.
• Can be trusted by Regulatory Affairs (RA)management as an independent regulatory core team lead on project teams
• Strong organizational skills and time management skills
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
• Ability to work independently and under general direction only
• Ability to manage conflict with and motivate teammates on project teams

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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