In this role, you have the opportunity to
To lead a team of 7 RA professionals and simultaneously represent RA in the Project Management team. As the Senior Regulatory Affairs Manager at Philips Image Guided Therapy Systems (IGT-S) you provide strategic input during product creation process and support in developing the department’s overall regulatory strategy. You work closely with Product Development, Medical / Clinical Affairs and Marketing and Sales. Are you looking for a challenge to manage your own team of RA experts and leading the Roadmap challenges in the different regulatory affair activities such as new project introductions, maintenance projects and process improvements? Please read further and we are looking forward to receive your job application!
You are Responsible for:
Work according the business applicable processes and as ambassador of the Philips values.
Manage, mentor and coach regulatory resources in their development.
Exercise supervision in terms of budgets, schedules, methods and staffing
Establishes operational objectives and work plans, and delegates assignments to subordinates.
Keeps abreast of current regulatory procedures and changes
Key role in (external) audits related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.
(support)Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance.
Responsible for developing and implementing global regulatory and roadmaps though deep understanding of the competitive market landscape , regulatory/ legislative initiatives, and product marketing strategy for their responsible products within IGT-S Fixed portfolio
Responsible for product registrations/approvals in her/his field.
Leads regulatory resources as part of projects (s)he works in.
To succeed in this role, you should have the following skills and experience:
Minimal of 6-9 years of experience in the medical device industry and technical environment with at least 5 years in an Imaging Diagnostic 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 devices worldwide
Strong background in Design Controls
Excellent working knowledge of medical device regulations (21CFR), FDA Law, MDD, other global laws and regulations.
Experience in supporting international registrations and clinical investigations
Approx. 20% travel annually with some international.
Bachelor’s degree in a technical discipline
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
Intention to offer a permanent contract at once
A market conform salary
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
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 3 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 at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.