Passionate about the fight against Cancer?
SimBioSys is on a mission to transform decision making and patient experience through computational simulations. By virtualizing cancer, clinicians and patients are empowered with a better understanding of the disease and can assess all available options computationally to truly individualize treatment.
SimBioSys deploys a combination of biophysical modeling and artificial intelligence to enable precision medicine in Cancer Care. Our portfolio of software applications enable individualized cancer care, drug development, clinical trial optimization and comprehensive biomarker development.
SimBioSys is seeking an experienced executive to lead the regulatory strategy and FDA approval for the company's current and future offerings for clinical decision support applications"
What You Will Do:
- Acting as liaison between company and FDA (and other agencies) for the company’s entire product portfolio
- Coaching and directing team to produce excellent work in compliance with best practices
- Establishing and directing the company’s regulatory roadmap in accordance with both company strategy and regulatory requirements
- Providing guidance to multidisciplinary teams on the content, format, style and architecture of submissions to the FDA and other regulatory agencies
- Leading the writing, review and preparation of more complex applications.
- Managing the organization, preparation and review of new filings, amendments, supplements, annual reports and other regulatory documents and correspondence
- Performing critical analyses of data and independently develop interpretations and conclusions for discussion/consideration with the SimBioSys leadership team, board, and consulting agencies
- Provide training on applicable requirements for regulatory, development, sales, and scientific staff as required
- Minimum of 7 years of experience in Regulatory Affairs in the medical device, pharma/biotech or diagnostics industry
- Minimum of 3 years of management experience
- Prior experience in AI/ML or in Digital Health a plus
- Experience in FDA regulatory submissions
- Strong written and verbal communication skills
- Advanced understanding of software regulatory requirements and best practices
- Highly motivated and independent thinker
- Strong attention to detail and clarity
- Prior Experience working or with FDA
- Advanced degree in life sciences or masters degree in technical field