Regulatory Affairs Director IGTS-MoS
3 weeks ago
Job Title: Director Regulatory Affairs IGTS-MoS
Job Description:
Detailed Role:
- Lead the Global Image Guided Therapy MoS Regulatory Affairs team, driving innovation and delivering high-quality regulatory affairs input and deliverables for new product introductions and product changes worldwide.
- Collaborate with cross-functional category leadership teams to understand patient and market needs and develop creative strategies for bringing new devices and device changes to market.
- Develop and implement processes to ensure an effective Quality System, driving improvement in regulatory aspects of Quality.
- Provide mentorship on global compliance, focusing on US, EU, Canada, Japan, and China, as well as product registrations and clinical evaluations in accordance with applicable regulations.
- Ensure compliance with current regulatory procedures and update procedures as new regulatory requirements become effective.
- Support clinical and pre-clinical studies, recommending strategies to optimize clinical study approvals in support of future marketing applications to health authorities.
- Advise on regulatory policy in line with Philips regulatory policy.
- Represent Regulatory Affairs in activities and due diligence concerning potential and executed mergers and acquisitions.
About the Ideal Candidate:
- Minimum of a Master's Degree in a Life-Sciences discipline or Regulatory/Quality/Health-related discipline(s).
- Minimum of 15+ years' experience working in Regulatory Affairs within medical device/technology environments, with 8+ years as a functional leader and a strong track-record successfully leading a Regulatory Affairs team bringing products to market on time.
- Experience with SaMD, AI, and/or digital health is highly desired.
- Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), PMA, Technical Files/Design Dossier).
- A strong background in Design Controls, percutaneous catheter devices, SaMD, SiMD, AI, and/or digital health.
- Extensive knowledge of MDD, MDR, MedDev's, FDA QSR's, ISO 13485 & 14155, and other applicable major/regional worldwide regulations.
- Working knowledge in regulations concerning device labeling as well as advertising and promotion.
- Shown leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to improve product market access.
About Philips:
We are a health technology company driven by the belief that every human matters. We aim to provide quality healthcare to everyone, everywhere. Do the work of your life to help the lives of others at Philips. Learn more about our commitment to diversity and inclusion.
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