Head of Regulatory, EMR & CM

Job Title

Job Description

Effective Wednesday, December 8, 2021, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.

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.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Within this Regulatory role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions with your regulatory expertise. This requires being a confident advisor and mentor in compliance to regulatory affairs, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.

As the Director of Regulatory Affairs, you will lead and manage global teams of Regulatory Affairs professionals responsible for all Regulatory activities in support of Connected Care – a Philips business, which has critical global evidence generation needs.

This role is part of the management team (MT) reports solid line to the Head of Regulatory Affairs, Connected Care, and a dotted line to the business group owner and will require 50% travel.

You are responsible for

• Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
• Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE Marking, product registrations, and clinical evaluations.
• Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
• Plan, generate, coordinate and responsible for regulatory submissions for product clearances/approvals/solution licensing
• Ensure the quality, content and format of regulatory submissions and for communication and teamwork with project team members.
• Coordinate conformity assessment strategy/plans required to support regulatory submissions
• Maintain existing regulatory filings/ licenses, managing updates and related change control processes (generally at the BIU and field level)
• Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
• Advise the project teams on applicable regulatory guidances and other appropriate product regulations that impact the development of product candidates.

• Participate in and advise cross-functional teams on applicable regulations, requirements, and standards, as applicable to Businesses and not to Markets
• Review and approve product/solution labeling and product/solution-related marketing communications
• Create and ensure execution of the Labeling Plans for products.
• Responsible for safety of consumer products and ensure root cause analysis of safety incidents and product non compliances with proper follow up of product improvements, as applicable to PH only
• Responsible for identification and support implementation of site certifications to support approbations

To succeed in this role, you’ll need a customer-first attitude and the following

A person who has strong technical competencies and demonstrates resilience in challenging and often demanding situations. We are looking for an individual that displays original, “out of box” thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention. We are looking for a perfectionist- a problem solver who continuously strives for excellence. We’re looking for someone who can inspire others to adopt this mentality of prioritizing regulatory prowess and quality above all else in a relentless pursuit to improve the quality of life for the billions of people Philips brand touches each and every day.

• This position requires a Master’s degree, RAPS Certified.
• 10 years of experience in the medical device industry and technical environment with at least 5 years in a medical device company (FDA Class II equivalent – Class III a plus).

Must have experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide. Strong background in Design Controls. Excellent working knowledge of medical device regulations (21CFR), Software as Medical Device (SaMD) and Software in Medical Device (SiMD) experience, FDA law, MDR, other medical device global laws and regulations. Experience in supporting international registrations and clinical investigations.

In return, we offer you

How we work at Philips

Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:

We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.

We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.

We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.

Philips Electronics Ltd is committed to treating all people in a way that allows them to maintain their dignity and independence. We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

#LI-PH1

#LI-Remote