Senior Regulatory Affairs Specialist (m/w/d) Medical Device

Job Title

Job Description

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

• Develop global regulatory strategies to meet business objectives and collaborate across a matrixed organization to ensure global success of products

• Participate in cross-functional project teams and provide regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy for new product introduction

• Responsible for worldwide product registration submissions/approvals as well as license renewals and updates.

• Prepare FDA and Health Canada submissions and European Technical Documentation (EU MDR) for product changes and/or new product introductions.

• Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed

• Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements.

• Analyze and optimize RA processes together with cross functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs in order to improve procedures or integrate new and changing Standards and regulations

You are part of

Philips Medical Systems Böblingen GmbH, an established leader in patient monitoring. We develop and produce patient monitoring systems for a worldwide market. Our products are used in emergency and intensive care, pregnancy and neonatal monitoring, as well as for anesthesia. You are joining a growing and dynamic Regulatory Affairs department with colleagues collaborating globally.

To succeed in this role, you should have the following skills and experience

• Degree in mechanical engineering, electrical engineering or applied sciences or related discipline

• Prior proven experience of the 510(k) or Q-Sub or De Novo or PMA Submission and approval Process

• Several years of experience plus professional experience in medical device regulatory affairs

• Strong experience creating other global regulatory submission plans, submission file preparation and receiving submission approval (EU, Canada, etc)

• Expertise with interpreting and implementing various medical device standards and global medical devices,

• such as electrical safety, EMC testing (e.g., IEC 62304, IEC60601 series etc.)

• Experience with systems for quality management, product development and follow-up of procedures is an advantage.

• Experience in process improvement, process implementation, facilitation of critical meetings.

• Experience in project management is required.

• Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP etc.)

• Coaching/mentoring skills to develop talents is required.

• Fluent in English, other European languages beneficial

In return, we offer you

We believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule, and access to local well-being-focused activities. Philips encourages people with a disability to apply.

• Attractive non-tariff-based compensation

• Annual salary adjustments and bonus

• 30 days of annual leave

• Purpose: Doing meaningful work with a great team

• Hybrid work concept: Up to two days a week "working from home"

• Philips Pension Fund: Employer-funded pension plan

• Mobility and devices: Leasing bicycles, cars, and also smartphones for private use

• Culture: Informal culture, a paid day for voluntary work, various team/cultural activities (on sustainability, diversity, ...), etc.

• Philips University: Wide range of professional training courses and for personal development

• Philips MyShop: Discount on Philips products

• Philips in Balance: Various offers for physical and mental health and sports courses

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 improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it's like working for Philips personally, visit the Working at Philips page on our career website. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status.

Please apply only online using the button/link below and upload your complete application documents to our application system (cover letter, CV and relevant certificates). To attach more than these documents, please click on "Zurück" in the browser window and then upload additional attachments.

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