Senior Regulatory Affairs Manager

The Senior RA Manager is a combination of People and Regulatory roadmap management.

You manage your project RA experts and represent RA in the Project Management team.

There you provide strategic input during product creation process and support in developing the department's overall regulatory strategy. At Philips Image Guided Therapy Systems (IGT-S) the Senior RA Manager cooperates closely with Product Development, Medical / Clinical Affairs and Marketing and Sales. We are looking for a regulatory affairs expert that has experience of medical device submissions (FDA, Health Canada, EU, etc.) and is looking for a challenge in managing her/his project RA experts and leading the Roadmap challenges in the different regulatory affair activities such as new project introductions, maintenance projects and process improvements.

Work according to 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

Establish operational objectives and work plans, and delegate assignments to subordinates.

Keep abreast of current regulatory procedures and changes

Take a key role in (external) audits related to product submission such as FDA, MFDS, notified body etc.

(Support)review and recommend changes for labeling, and clinical protocols to maintain regulatory compliance.

Develop and implement global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives, and product marketing strategy for the products within IGT-S Fixed portfolio

Undertake and manager product registrations/approvals in your field.

Lead regulatory resources as part of projects you manage.

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.
• Bachelors degree in a technical discipline
• RAPS certified(preferred)