Regulatory Affairs Director for Image Guided Therapy Systems

7 days ago

Pune, Maharashtra, India Philips Full time

Job Title: Regulatory Affairs Director for Image Guided Therapy Systems

Job Description:

Regulatory Affairs Director for Image Guided Therapy Systems

Critical RA leader of the IGTS MoS Category (Image Guided Therapy Systems Mobile Surgery). Also, a member IGTS MoS Leadership Team and advise senior management on matters concerning several functional areas and/or customers.

Your Role:

As the Head of Regulatory Affairs for the IGTS MoS team, you will have a rewarding opportunity to utilize your Regulatory Affairs/Compliance expertise and critical leadership abilities in leading the Image Guided Therapy MoS Business.

Your contributions and expertise in formulating regulatory strategy/policy for this business with the underlying categories, while also being involved in developing, modifying, and executing company regulatory strategies and policies, will play an important role in improving and saving lives around the world.

  • Leading and developing the Global Image Guided Therapy MoS Regulatory Affairs team from end to end (product inception through to lifecycle management), driving significant innovation, actively providing value-added regulatory affairs input and deliverables for new product introductions and product changes across the globe.
  • Partnering with a cross-functional category leadership team (e.g., Marketing, R&D, Clinical, Quality) to understand patient and market needs and developing creative strategies for bringing new devices and device changes to market.
  • Driving improvement in regulatory aspects of the Quality System, developing processes and detailing procedures to ensure an effective Quality System.
  • Reviewing and recommending changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
  • Providing mentorship on global compliance, with a focus on US, EU, Canada, Japan, and China, as well as product registrations and clinical evaluations in accordance with applicable regulations.
  • Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements become effective.
  • Providing regulatory support for clinical and pre-clinical studies, including recommending strategies to optimize clinical study approvals in support of future marketing applications to health authorities.
  • Advising on regulatory policy in line with Philips regulatory policy.
  • Representing Regulatory Affairs in activities and due diligence concerning potential and executed mergers and acquisitions.

You're the Right Fit If:

  • Minimum of a Master's Degree in a Life-Sciences discipline (biology, biochemistry, chemistry, microbiology, immunology, pharmacology) 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.
  • A passion for continuous improvement with associated change management, particularly around transformation, integration, and organizational design.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

• Learn more about our company.

• Discover our mission.

• Learn more about our commitment to diversity and inclusion.

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