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Director of Regulatory Affairs

4 months ago

California, United States TGI Life Sciences Full time

Are you passionate about revolutionizing healthcare through innovative medical devices and cutting-edge AI technology? We are seeking a dynamic and experienced Director of Regulatory Affairs to join our team in the vibrant San Francisco Bay Area.

If you thrive in a fast-paced environment, are driven by challenges, and are eager to make a significant impact in the healthcare industry, this could be the perfect opportunity for you.

About Us: We are a pioneering medical technology company dedicated to transforming gastrointestinal healthcare. Our flagship product is a revolutionary capsule endoscopy system that provides unparalleled diagnostic capabilities, leveraging advanced artificial intelligence algorithms to enhance medical imaging and diagnosis. At our company, we are committed to pushing the boundaries of innovation to improve patient outcomes and revolutionize the way gastrointestinal diseases are diagnosed and managed.

Position Overview: As the Director of Regulatory Affairs, you will play a crucial role in ensuring regulatory compliance and facilitating the successful commercialization of our groundbreaking medical devices. Reporting to the Vice President of Regulatory Affairs, you will lead the regulatory strategy and execution, collaborating closely with cross-functional teams to navigate the complex landscape of regulatory requirements and drive the expansion of our product portfolio.

Key Responsibilities:

  • Develop and execute regulatory strategies to support the global registration and commercialization of our medical devices.
  • Lead regulatory submissions, including 510(k) submissions, CE marking applications, and international product registrations.
  • Serve as the primary point of contact with regulatory agencies and notified bodies, addressing inquiries, providing documentation, and ensuring compliance with applicable regulations and standards.
  • Stay abreast of changes in regulatory requirements and industry standards, and proactively assess the impact on our products and processes.
  • Provide strategic guidance and leadership to cross-functional teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure regulatory requirements are integrated into product development activities.
  • Oversee post-market surveillance activities, including adverse event reporting, labeling updates, and regulatory communications.

Requirements:

  • Bachelor’s degree in a relevant scientific or technical field; advanced degree preferred.
  • Minimum of 7 years of experience in regulatory affairs within the medical device industry, with a focus on AI-based technologies.
  • Strong understanding of regulatory requirements for medical devices, including FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), ISO standards (e.g., ISO 13485, ISO 14971), and international regulatory frameworks.
  • Proven track record of successful regulatory submissions and interactions with regulatory agencies (FDA, Notified Bodies, etc.).
  • Demonstrated leadership experience in regulatory affairs, including managing a team and driving regulatory strategy.
  • Ability to thrive in a fast-paced startup environment and contribute to the scaling-up of small companies.
  • Excellent communication skills and ability to collaborate effectively with cross-functional teams.
  • Strong attention to detail, problem-solving skills, and ability to work independently with minimal supervision.

Why Join Us?

  • Opportunity to work at the forefront of medical technology innovation, shaping the future of healthcare.
  • Collaborative and dynamic startup culture with a focus on teamwork, creativity, and continuous learning.
  • Competitive compensation package, including salary, stock options, and comprehensive benefits.

How to Apply: If you are excited about the prospect of joining our team and leading our regulatory efforts to make a meaningful impact in the healthcare industry, please submit your resume and cover letter to cmott@tgilifesciences.com. In your cover letter, please highlight your relevant experience in regulatory affairs, medical devices, and AI technologies, as well as your motivation for joining our team.

We are an equal opportunity employer and value diversity in the workplace. We encourage applicants from all backgrounds to apply.

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