Director or Regulatory, Software and Artificial Intelligence
at
Philips
Bothell, Washington, USA
-
Full Time
Start Date
Immediate
Expiry Date
10 Oct, 25
Salary
275520.0
Posted On
11 Jul, 25
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Good communication skills
Industry
Pharmaceuticals
Description
Responsibilities
Lead a global Regulatory Affairs team for end-to-end regulatory affairs input and deliverables for regulatory strategy development of new product introductions, maintaining clearances and product changes across the globe. Through end-to-end regulatory processes, ensure safe and effective products/solutions are brought to market, on time, and sustained throughout the life cycle via compliant, innovative regulatory strategies. Provide critical input on regulatory risk assessments to support portfolio selection.
Build proactive, strategic relationships with external stakeholders (notified Bodies, U.S. FDA, Competent Authorities, etc.) to ensure that requirements are known early during strategy development, which enables fast market access with the current portfolio in connection with future innovations. Advise the regulatory and cross functional teams on the best communication and resolution strategies to address issues raised by government authorities during product reviews or audits
Represent the regulatory affairs function within the Ultrasound Leadership Team.
Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Product Management, Quality, Medical & Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips market organization.
Responsible for the hiring and development of critical talent within the global regulatory affairs team through creating and sustaining robust development plans, ongoing coaching, and feedback, and identifying and addressing capabilities gaps.
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