Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist (U.S. Hub based location) The Principal Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex new devices and post market changes within our Ultrasound business.Your role:

You will lead business critical new product development projects, provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art requirements are maintained; Develop regulatory strategies and communicate risks within regulatory strategies vs project plan, and outline proposal for balancing the project risk to project teams and Regulatory Affairs Management.

Lead communication and negotiation efforts with regulatory enforcement entities on regulatory filings at the reviewer level; Providing Guidance on global compliance such as CE Marking and product registrations, clinical evaluations in accordance with EU MDR, ISO 13485, and ISO 14155, China NMPA, Canada, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall Philips Ultrasound priorities globally.

Ensuring compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect; Providing regulatory support for (pre) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.

Representing Philips in internal and external audits with regulatory agencies or Notified Bodies as needed.

Mentor and coach Philips regulatory professionals in their development; drive improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained.

You're the right fit if:

You’ve acquired 7+ years of experience in Medical Device Regulatory Affairs, first line experience with U.S. FDA, China NMPA, and EU MDR is required. International regulatory submission authoring experience is required. Must have experience with successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. Experience with Software as Medical Device, and Ultrasound Imaging Devices is preferred.

Your skills include strong understanding of all relevant global regulatory requirements, flexibility and adaptability to adjust to business needs, and strong communication skills. RAC preferred.

You have a Bachelors degree in a technical or business discipline required, advanced degrees preferred.

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) position.

You’re an team player with an ability to work in a matrixed environment with teams in different locations. Minimal travel required (<10%).

About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency Details The pay range for this position is $96,850 to $200,256, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here (https://www.careers.philips.com/na/en/best-employee-benefits) . At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Listed posting location.#LI-PH1It 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