Senior Director, Regulatory Affairs
In this role you will be advising our business on regulatory and clinical strategy and requirements for specific new product/solutions. You will complete integration efforts within the IGT (Image Guided Therapy) group focused on consolidating multiple sites in alignment with Quality Systems and Philips Corporate requirements. Our Sr Director of Regulatory Affairs will also focus on partnering with the Government Affairs, Global Regulations, & Standards team to align RACA activities and representation of Philips in the necessary industry associations.
Key Areas of Responsibility:
- Advise business RACA teams on applicable regulations, requirements, and standards through the development of regulatory plans and / or clinical study plans.
- Lead RACA programs to ensure the highest level of compliance.
- Develop market submission strategy for new products/solutions (to include definition of all deliverables and/or localization required).
- Direct markets medical product approvals process and submissions when necessary. (Note: supports CE Medical marking which is under Business Group responsibility. The 510K process is completely excluded).
- Plan, generate, lead and coordinate regulatory submissions for product/solution licensing.
- Coordinate testing required to support regulatory submissions in specific markets.
- Maintain existing regulatory filings/ licenses, leading updates and related change control processes
- Establish and deploy systems to ensure that the information required for all requiredreports, product registration certificate renewals and submissions are clearly identified can be easy retrieved. This includes the creation of a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals
- Review and approve localized product/solution labeling and product/solution-related marketing communications and ensure that all medical and technical claims are underpinned with evidence obtained by business Q&R
This position requires:
- Proven leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to maximize product market access.
- A comprehensive understanding of the diverse worldwide medical device regulations, the experience to know how to successfully apply those regulations in an efficient, effective and compliant manner.
- Proven experience in understanding consequences of new and changing regulations to markets and business groups and effectively and actively transferring this knowledge and understanding to all applicable partners to ensure timely compliance with these regulations and guaranteeing continuous market access.
- An ability to successfully lead virtual teams of RACA professionals existing of both direct and functional reports in order to effectively and efficiently execute pre-market approval and post-market surveillance processes.
- Proven experience in successfully representing organizations in industry associations.
- The experience to lead and develop strategies for a multi-site, global healthcare business while also being able to design and execute specific projects and lead teams.