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.
In this role, you have the opportunity
As a core member of multiple sustaining and new product development teams, the Sr Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) mostly independently with periodical supervisor’s support by owning the following tasks:
You are responsible for:
- Lead a team within Regulatory or Cross Functional Team to set and deliver the objectives
- Communicate application progress to internal stakeholders
- Collaborate with worldwide colleagues regarding license renewals and updates
- Maintain regulatory files and tracking databases as required
- Communicate with regulatory agencies as needed
- Ensure standard and process compliance.
- Provide audit, CAPA and post market regulatory support
- Mentor other regulatory affairs personnel within HPM Regulatory
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you’ll need a customer-first attitude and the following
- Bachelor’s degree or equivalent internationally acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
- Minimum 6 years of regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.)
- 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
- Experience with Authoring FDA 510(k) submissions
- Experience with SaMD and familiar with Artificial Intelligence and Machine Learning
- RAPs RAC strongly preferred
- Understand LEAN concepts, methodologies and deployment
- Proficient computer skills in Microsoft Office
- May require 5% travel annually with possibly some international
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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.
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.
Equal Employment and Opportunity Employer/Disabled/Veteran
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Regulatory Affairs Manager 60
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