About

• Bachelor's degree required; Advanced degree preferred. 15+ years of experience in Regulatory Affairs and/or HEMA within the pharmaceutical and/or medical device industry. 10+ years of direct management experience leading global teams. Proven leadership in developing and executing global Regulatory and HEMA strategies. Expertise in regulatory pathways including PMA, IDE, 510(k), EU MDR, NDA, IND, FDA pre-submissions and international registrations including China and Japan. Demonstrated expertise in global healthcare systems / markets and economics of healthcare reimbursement with a focus on US healthcare and CMS. Experience with device and combination products, specifically with cancer therapies. Established relationships with global regulators and payers. Demonstrated ability to influence key economics purchasers including customers, payers, and governments. Ability to interpret regulations and apply to business needs. Demonstrated understanding of commercial, operational, and functional aspects of the business and success in managing complex matrixed organizations and influencing cross-functional teams. Ability to travel domestically and/or internationally as required. Strong leadership skills with high customer focus. High degree of integrity and professionalism. Ability to build relationships and influence internal and external stakeholders. Experience in IO&E or related interventional therapies is highly desirable.