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VP of Regulatory Affairs



Remote · United States
Posted on Wednesday, July 12, 2023
Work at Radformation
Cancer rates increase year after year, yet high-quality care is not universal. By automating and standardizing the treatment planning workflow, Radformation aims to create a system where any patient anywhere can receive the same high-quality care.
We strive daily to reduce cancer's global impact and help save more of the 10 million lives it claims each year. Our unwavering commitment is to deliver reliable, high-quality, automated solutions that allow clinics to standardized care for every single person in need.
Radformation is seeking a self-motivated VP of Regulatory Affairs to join an innovative team. As Radformation sets out to scale, the VP of Regulatory Affairs will work directly with our regulatory team to:
- Develop and execute regulatory strategies
- Improve the internal quality management system and regulatory processes
- Compiles regulatory submissions
- Provide support to currently marketed products as necessary.
Regulatory Affairs is a multidimensional discipline. As part of a smaller team environment, you will have the opportunity to work with all aspects of the Regulatory profession.


  • Lead and mentor the regulatory team
  • Lead the preparation of Regulatory submissions
  • Work with regulatory agencies and partners worldwide to achieve market access and compliance.
  • Manage the quality management system and comply with ISO 13485.
  • Ensure compliance with regulations.
  • Explain regulations, policies, or procedures.
  • Work cross-functionally with product and engineering teams to ensure cohesive and compliant product development and commercialization processes.
  • Provide technical review of data and reports.
  • Coordinate regulatory documentation activities.
  • Coordinate usability testing, clinical evaluations, and literature reviews.
  • Monitor changes to regulatory environments and update internal stakeholders to ensure the organization's readiness to meet new requirements.
  • Support post-market regulatory compliance activities.

Required Experience

  • MS in Regulatory Affairs or RAC Certified (Medical Devices)
  • 10+ years of regulatory affairs experience in Radiation Oncology
  • Proven experience in managing regulatory submissions with a strong understanding of US FDA and EU MDR.
  • Experience with Quality Management Systems and ISO 13485
  • Highly motivated
  • Strong analytical and project management skills
  • Passionate about mentoring and leading a team
  • Excellent communication and interpersonal skills
  • The ability to think strategically, multi-task, and meet deadlines
  • Experience with numerous markets and the understanding of the nuances between segments
What makes us so RAD?
We take care of our people!
Radformation offers top-tier medical, dental, vision care for employees and their families. Each role comes with stock options*, our 401(k) & employer match vest immediately and you'll never have to stress about taking the time you need with self-managed PTO. We support our growing RAD families with generous parental leave, along with additional part-time work to help transition back into the swing of things. We are a fully remote team and while we may be apart, virtual events, yearly retreats and a collaborative work environment keep us close and connected.
Cancer transcends any individual differences we may have. That's why at Radformation we celebrate diversity and are committed to creating an inclusive environment for all employees. We are proud to be an equal opportunity workplace and an affirmative action employer.
*Stock options are offered to US-based employees only.