Regulatory Affairs Director, IGTS-MoS

3 weeks ago


Pune, Maharashtra, India Philips Full time

Job Title

Director Regulatory Affairs IGTS-MoS

Job Description

Regulatory Affairs Director for IGTS-MoS

Critical RA leader of the IGTS MoS Category (Image Guided Therapy Systems Mobile Surgery) is sought for a rewarding opportunity to utilize 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 current regulatory procedures and updating 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.



  • Pune, Maharashtra, India Philips Full time

    Job Title: Director Regulatory Affairs IGTS-MoSJob Description: Director Regulatory Affairs IGTS-MoS:Critical RA leader of the IGTS MoS Category (Image Guided Therapy Systems Mobile Surgery) with a strong background in formulating global strategies to ensure compliance with worldwide regulations.As the Head of Regulatory Affairs for the IGTS MoS team, you...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Director Regulatory Affairs IGTS-MoSJob 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...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Director Regulatory Affairs IGTS-MoSJob Description:Director Regulatory Affairs IGTS-MoSCritical 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...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Regulatory Affairs Director for Image Guided Therapy SystemsJob Description:Regulatory Affairs Director for Image Guided Therapy SystemsCritical 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...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Are you looking for a challenging role in regulatory leadership where you can build advocacy and accelerate product development and licensure on a global scale, with a focus on the US? If so, this Director, Global Regulatory Affairs, Vaccines position could be an exciting opportunity to explore.As a Director, Regulatory Affairs, Vaccines, you will be...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Are you looking for a challenging role where you can build a strong regulatory strategy and accelerate product development and licensure on a global scale, with a focus on the US? If so, this Director, Global Regulatory Affairs, Vaccines position could be an exciting opportunity to explore.As a Director, Regulatory Affairs, Vaccines, you will be responsible...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    At 9627 Corixa Corporation, we're committed to making a positive impact on the health of millions of people worldwide. Our team is dedicated to discovering and delivering innovative vaccines and medicines to prevent and treat diseases.Job Purpose:We're seeking a highly skilled Global Regulatory Affairs Director to join our team. As a key member of our...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Global Marketing Director Mobile SurgeryJob Description:As a Global Marketing Director for Mobile Surgery, you will be responsible for leading the global marketing efforts for the Mobile Surgery business within the IGT Systems organization.Your Challenge:You will be part of the IGT Systems Mobile Surgery Management team and will report to the...


  • Pune, Maharashtra, India Pharmabharat Full time

    Company OverviewPharmabharat is a Clinical Research Organization (CRO) dedicated to advancing clinical trials in the healthcare industry. With its headquarters in India, our team of professionals is committed to supporting innovative healthcare solutions. For more information, visit our website at Pharmabharat.com.Job OverviewWe are seeking a Regulatory...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Job SummaryThe Director, Global Regulatory Affairs, Vaccines will be responsible for developing and executing the appropriate Regulatory strategy(ies) for assigned US asset(s), across all stages of the product life cycle and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP).Key Responsibilities:Accountable to the asset GRL and/or...


  • Pune, Maharashtra, India Avient Full time

    Job SummaryThe Regulatory Affairs Specialist will support the Product Stewardship team in managing global regulatory matters, collaborating with internal and external partners, and ensuring compliance with chemical legislation. The role involves developing and implementing regulatory information systems, providing training and support to the team, and...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Job SummaryWe are seeking a highly skilled Senior Manager, CMC Facilities Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our manufacturing facilities and equipment.Key Responsibilities:Develop and implement regulatory strategies for CMC...


  • Pune, Maharashtra, India Avient Full time

    Job SummaryThe Regulatory Specialist plays a crucial role in the Product Stewardship team, responsible for managing all regulatory matters for the global business. This involves liaising with global company locations and customers in various regions, including Europe, Asia, North America, and Latin America.Key Responsibilities:• Develop and implement...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Job Purpose: Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    At 9627 Corixa Corporation, we strive to positively impact the health of millions of people worldwide. Our R&D team is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are revolutionising the way we do R&D, uniting science, technology, and talent to get ahead of disease...


  • Pune, Maharashtra, India 9627 Corixa Corporation Full time

    Job Title: Global Regulatory Affairs Strategy LeaderAbout 9627 Corixa CorporationWe are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together.We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Global Marketing Director Mobile SurgeryYour Role:Develop and execute the global marketing strategy for Mobile Surgery, aligning with the overall business IGT Systems vision.Lead a team of product managers and clinical application specialists, driving upstream marketing activities, defining commercial specifications, and ensuring market...


  • Pune, Maharashtra, India Philips Full time

    Job Title: Global Marketing Director Mobile SurgeryJob Description:As a Global Marketing Director for Mobile Surgery, you will be responsible for leading the global marketing efforts for the Mobile Surgery business within the IGT Systems organization. This role will require you to develop and execute a comprehensive marketing strategy that aligns with the...


  • Pune, Maharashtra, India Philips Full time

    About the Role:This is an exciting opportunity to lead the global marketing efforts for our Mobile Surgery business, a key area of focus for Philips. As the Global Marketing Director, you will be responsible for developing and executing a comprehensive marketing strategy that drives business growth and customer engagement.Key Responsibilities:Develop and...


  • Pune, Maharashtra, India Hyatt Corporation Full time

    Financial Operations DirectorHyatt Corporation seeks an experienced Financial Operations Director to lead the accounting and finance team at our Hyatt Place locations.Key ResponsibilitiesManage the efficient operation of the finance department in line with Hyatt International's Corporate Strategies and brand standards.Ensure timely and accurate financial...