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Sr. Regulatory Affairs Manager

4 months ago

Orlando, Florida, United States Philips Full time

Senior Regulatory Affairs Manager (U.S. Hub based location)

The Senior Regulatory Affairs Manager will develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and sustaining programs for Philips Ultrasound.

Your role:

  • Manage a team of around 5 direct reports working on both NPI and sustaining projects. Ability to provide mentorship to team members is important.
  • Driving improvement in regulatory aspects of the Quality Management System (QMS) and in developing processes and documenting procedures to ensure an effective Quality System is maintained. Reviewing and recommending changes for design control processes and manufacturing procedures to maintain quality and regulatory compliance.
  • 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, Canadian CMDCAS, 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 updating the 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 Ultrasound Regulatory Organization in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body

You're the right fit if:

  • You've acquired 7+ years of experience in a similar role within Regulatory Affairs in the medical device industry, with at least 3+ years of experience managing a team in a similar function. Hands on experience preparing submissions for new product introductions is required. Experience with 510(k) submissions and class 2/2a for EU required. Experiences surrounding international regulatory submissions and registrations required.
  • Your skills include software as a medical device (SaMD), AI, and imaging devices experience strongly preferred. First line experience with US FDA and EU MDD/MDR required. Detailed knowledge of ISO 13485 and QSR registrations. Experience with successful preparation and submission of Technical Documentation, 510(k).
  • You have a bachelor's degree or higher in a science, technical, or business discipline.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote ,-cognitive-and-environmental-pce-job-requirements) position.
  • You're an team player who can work in a matrixed environment with teams in different locations. 5-10% travel may be required, domestic and international.

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.

  • Learn more about our business ) .
  • Discover our rich and exciting history. )
  • Learn more about our purpose. )
  • Read more about our 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 ) .

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 ) .

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 posted locations.

#LI-PH1

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 , option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran