Principal Regulatory Affairs Specialist-Coronary Vascular

2 months ago


San Diego, California, United States Philips Full time
Job Title

Lead Regulatory Affairs Specialist-Coronary Vascular

Job Summary

As a Lead Regulatory Affairs Specialist, you will have a key role in ensuring the safety, effectiveness, and compliance of Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products with global regulatory standards.

Role Highlights:
  • Provide guidance to internal teams (R&D, Marketing, Manufacturing, etc.) on laws, regulations, and guidelines related to the CV product line to ensure alignment with regulatory expectations and company goals.
  • Develop and execute global regulatory strategies, manage submission risks, and secure approvals for the US, Canada, EU, and other regions through innovative problem-solving approaches.
  • Mentor and lead Regulatory Affairs staff, engage with stakeholders and regulatory agencies, and support product certifications and audits.
  • Collaborate with the Director of Regulatory Affairs-Coronary Vascular and global teams on license renewals, NPD strategies, and regulatory requirements.
  • This role is Hybrid in San Diego, CA or Plymouth, MN with occasional travel.
  • No relocation assistance is offered; candidates must be situated near Plymouth, MN or San Diego, CA.
Desired Qualifications:
  • 7+ years of Regulatory Affairs experience in FDA-regulated medical device environments, including approvals, submissions, and knowledge in cardiovascular, imaging, and hardware/software devices.
  • Experience with SaMD and Artificial Intelligence/Machine Learning is a plus.
  • Strong expertise in domestic and international regulatory requirements, a Bachelor's degree is required, Master's preferred. RAPS RAC credential is advantageous.
  • Excellent communication skills, proficiency in Microsoft Office, and ability to handle tasks independently.
  • US work authorization is essential; sponsorship is not available.
About Philips:

Philips is a leading health technology company dedicated to providing quality healthcare globally. We prioritize inclusivity and aim to make healthcare accessible to all. Join us in making a difference.
  • Explore our business initiatives.
  • Learn about our rich history.
  • Understand our mission and values.
  • Discover our employee perks.
If you believe you have the potential for this role even with some skill gaps, we encourage you to apply. Learn more about our diversity initiatives and join us at Philips.

Philips Compensation:

The salary range for this role is $97,000 to $178,000 per year, dependent on experience, skills, and location.

This job posting will be active for 45 days or until filled. Early applications are recommended. Philips is an equal opportunity employer, promoting diversity and creating an inclusive workplace environment.

  • San Diego, California, United States CorDx Full time

    About CorDxCorDx is a global biotechnology firm dedicated to advancing innovation and supply in the realm of global health. With a workforce exceeding 2,100 professionals worldwide, we serve millions of users across more than 100 countries. Our focus is on delivering rapid testing and point-of-care medical device solutions for the detection of infectious...


  • San Diego, California, United States Modular Medical Inc Full time

    Job OverviewInternational Regulatory Specialist (EU MDR) - Medical DevicePosition SummaryThe International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and is responsible for overseeing the international regulatory submission framework.Essential Qualifications:Required - Minimum Qualifications:Education: Bachelor's...


  • San Diego, California, United States Modular Medical Inc Full time

    Position OverviewInternational Regulatory Specialist (EU MDR) - Medical DeviceRole Summary:The International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and oversees the comprehensive international regulatory submission process.Essential Qualifications:Required - Minimum Qualifications:Education: Bachelor's...


  • San Diego, California, United States Modular Medical Inc Full time

    Position OverviewInternational Regulatory Specialist (EU MDR) - Medical DeviceRole Summary:The International Regulatory Specialist is primarily accountable for ensuring adherence to EU regulatory standards and oversees the international regulatory submission framework.Essential Qualifications:Required Qualifications:Education: Bachelor's degree in a relevant...


  • San Diego, California, United States INVIVOSCRIBE INC Full time

    Join Our TeamInvivoscribe is a premier organization committed to Precision Diagnostics aimed at improving lives. With over 25 years of expertise, we have been leaders in the global standardization of testing and providing access to innovative cancer therapies.Located in the dynamic region of San Diego, California, our international reach enables us to...


  • San Diego, California, United States CorDx Full time

    Regulatory Affairs Specialist Opportunity at CorDxCorDx, a prominent biotechnology firm committed to advancing global health, is seeking a Regulatory Affairs Specialist to enhance our proactive Regulatory Affairs division. In this pivotal role, you will be instrumental in ensuring adherence to FDA standards for our In Vitro Diagnostics (IVD) offerings.Key...


  • San Diego, California, United States Genalyte Full time

    Senior Regulatory Affairs SpecialistGenalyte, Inc., a frontrunner in cutting-edge diagnostic solutions, is seeking a highly qualified and driven Senior Regulatory Affairs Specialist to become part of their innovative team. In this position, you will be tasked with navigating intricate regulatory frameworks to guarantee adherence to all standards and...


  • San Diego, California, United States Katalyst HealthCares & Life Sciences Full time

    Position Title: Regulatory Affairs SpecialistCompany: Katalyst HealthCares & Life SciencesEmployment Type: ContractDuration: 12 monthsDepartment: Regulatory AffairsQualifications: Bachelor’s or Master’s degree in a relevant Scientific Discipline At least 7 years of experience in the pharmaceutical sector Minimum of 5 years of experience in CMC regulatory...


  • San Diego, California, United States CorDx Full time

    Regulatory Compliance Specialist Opportunity at CorDxCorDx, a prominent biotechnology firm committed to advancing global health, is seeking a Regulatory Compliance Specialist to enhance our proactive Regulatory Affairs division. In this pivotal role, you will be instrumental in ensuring adherence to FDA standards for our In Vitro Diagnostics (IVD)...


  • San Diego, California, United States Radionetics Oncology, Inc. Full time

    Position OverviewAbout Radionetics OncologyRadionetics Oncology, Inc. is a pioneering clinical-stage organization dedicated to the innovation and advancement of cutting-edge radiopharmaceuticals aimed at treating a diverse array of oncology conditions. The company is strategically positioned to leverage the growing demand for novel radiotherapeutics,...


  • San Diego, California, United States BD (Becton, Dickinson and Company) Full time

    Job OverviewThe Senior Regulatory Affairs Consultant plays a crucial role in formulating and implementing effective strategies for regulatory submissions and approvals related to intricate product development initiatives. This position collaborates with various projects and teams, providing essential guidance and regulatory insights to ensure swift global...


  • San Diego, California, United States Surf Search Full time

    Join Our Team as a Regulatory Affairs ManagerWe are seeking a skilled Regulatory Affairs Manager to become part of our client's team and have a significant role in introducing new products to the market. As the Regulatory Affairs Manager, you will be responsible for leading the regulatory strategy and overseeing submissions for new product releases within...


  • San Diego, California, United States Radionetics Oncology Full time

    About Radionetics OncologyRadionetics Oncology is a clinical-stage biotechnology company dedicated to the discovery and development of innovative radiopharmaceuticals for the treatment of various oncology indications. With a strong focus on novel radiotherapeutics, the company is poised to capitalize on the growing demand for effective cancer...


  • San Diego, California, United States Genalyte Full time

    Position OverviewGenalyte, Inc., a pioneer in innovative diagnostic solutions, is in search of a highly experienced and driven Senior Regulatory Affairs Specialist to enhance our dynamic workforce. In this crucial position, you will utilize your knowledge to navigate intricate regulatory frameworks, ensuring our revolutionary products adhere to all...


  • San Diego, California, United States Genalyte Full time

    Position OverviewGenalyte, Inc., a frontrunner in pioneering diagnostic technologies, is in search of a proficient and driven Senior Regulatory Affairs Specialist to enhance our innovative team. In this crucial position, you will utilize your regulatory expertise to navigate intricate compliance frameworks, ensuring our revolutionary products adhere to all...


  • San Diego, California, United States Katalyst Healthcares and Life Sciences Full time

    Key Responsibilities: Oversee and support regulatory policy initiatives within the Regulatory Science and Policy team. Demonstrate proficiency in navigating a matrix organization and managing uncertainty to facilitate decision-making across various teams. Collaborate with regulatory leads to provide cross-functional support on both strategic and...


  • San Diego, California, United States CorDx Full time

    Job OverviewAbout CorDx:CorDx is a global biotechnology firm dedicated to advancing innovation and supply in the realm of global health. With a workforce exceeding 2,100 professionals worldwide, we cater to millions of users across more than 100 countries. Our focus is on delivering rapid testing and point-of-care medical device solutions for the detection...


  • San Diego, California, United States Danaher Corporation Full time

    About Danaher Corporation: Danaher Corporation is a global leader in the life sciences and diagnostics sectors, committed to innovation and excellence in our products and services.Position Overview: We are seeking a Senior Specialist in Regulatory Affairs for Core and NGS Technologies. This role is integral to our Quality Assurance and Regulatory Affairs...


  • San Diego, California, United States Genalyte Full time

    Position OverviewGenalyte, Inc., a pioneer in innovative diagnostic solutions, is on the lookout for a highly experienced and driven Senior Regulatory Affairs Specialist to enhance our dynamic workforce. In this crucial position, you will utilize your regulatory expertise to navigate intricate compliance landscapes, ensuring our revolutionary products adhere...


  • San Diego, California, United States Cypress HCM Full time

    Exciting Opportunity in Regulatory AffairsAre you an experienced professional with a strong background in global regulatory management and project execution? As a pivotal member of Cypress HCM, you will be instrumental in advancing our objectives within the pharmaceutical sector. In the role of Regulatory Affairs Director, you will be responsible for...