Senior Regulatory Affairs Specialist
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
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
You are responsible for
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
- Create comprehensive regulatory strategies.
- Develop and prepare product registration submissions for the US, Canada, EU and support worldwide international submissions as assigned.
- Review and approve advertising, promotional items and labeling for regulatory compliance.
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
- Communicate application progress to internal stakeholders.
- Collaborate with worldwide colleagues regarding license renewals and updates.
- Communicate with regulatory agencies as needed.
- Support the site audit for the responsible products, including NB surveillance audit, FDA inspection, MDSAP audit, and all kinds of unannounced audits etc.
- Provide audit, CAPA and post market regulatory support as assigned.
You are a part of
The IGTD regulatory team responsible for the peripheral cardiovascular category.
To succeed in this role, you’ll need a customer-first attitude and the following
- Bachelor’s degree or Master’s degree in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
- Minimum 5 years of regulatory approvals and submittal experience (EU MDR, Health Canada, USA (PMA, 510k).
- Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
- Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
- Proficient knowledge of domestic and international standards.
- Regulatory Affairs Professionals RAC strongly preferred.
- Understand LEAN concepts, methodologies and deployment.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
Company relocation benefits will not be provided for this position. For this position, you will reside in or within commuting distance to Plymouth, MN
In return, we offer you
In order to develop your full potential, we will offer you the flexibility, encouragement and opportunities to keep you inspired and engaged. After all, working at Philips is more than a job. It is an experience full of amazing moments that will transform you in a lasting and positive way, since together we can improve the world.
Our benefits can be found here: https://www.careers.philips.com/na/en/total-rewards-at-philips
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 is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.