Sr. Regulatory Affairs Manager

USA (Remote)

Paige is a software company helping pathologists and clinicians make faster, more informed diagnostic and treatment decisions by mining decades of data from the world’s experts in cancer care. We are leading a digital transformation in pathology by leveraging advanced Artificial Intelligence (AI) technology to create value for the oncology clinical team.

We are the first company to develop clinical grade AI tools for the pathologist, which resulted in our receiving FDA breakthrough designation for our first product. Paige has also received FDA-clearance for our digital viewer, FullFocus™. We have also established multiple relationships with biopharma, laboratory, and equipment manufacturers that enables Paige to develop an ecosystem ready to help patients receive better diagnoses and treatment.

We’re seeking a Sr. Regulatory Affairs Manager who will be leading Paige’s regulatory affairs initiatives. While making progress on these initiatives, this individual will also assist with the regulatory submissions. This is an extraordinary opportunity to be part of a high-performing team and to pursue a life-changing mission with unique technical challenges!

This position can be fully remote for U.S. based applicants.

Responsibilities

  • Lead IVDR transition of CE/UKCA marked devices
  • Assist in q-sub/breakthrough submission preparations for FDA
  • Assist organizing company’s regulatory posture/framework
  • Revamp and maintain promotional materials review process
  • Assist in MDSAP expansion projects by providing regulatory insights and implementing appropriate changes
  • Assist in post-market surveillance framework
  • Assist in identification of low-burden regulatory clearance regions/countries

 Requirements

  • Experience with digital health and cutting-edge AI/ML SaMD products (ideally in digital pathology)
  • Extensive experience with IVDR and 21 CFR Part 820 regulations
  • Experience in assisting ISO 13485 & MDSAP certifications
  • Experience with external audits from regulatory bodies and clients
  • Bachelor’s degree in engineering or a related field, or equivalent years of experience.
  • 6+ years of industry experience in regulatory affairs