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

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 the lives of others.

• Learn more about

our business

.

• Discover

our rich and exciting history

.

• Learn more about

our purpose
.
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
.

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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 regulation

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 beneficia