Medical Device Regulatory Affairs Strategist

Oracle is seeking a Regulatory Affairs Strategist to navigate the complex regulatory landscape of the healthcare and life sciences industries. This role will involve preparing product documentation for global markets, establishing partnerships with business units, and ensuring compliance throughout the product lifecycle, from development to post-market activities. The ideal candidate is collaborative, problem-solver, and dedicated to excellence.

Requirements

• BA/BS or advanced degree preferred
• Experience with SaMD in medical device industry
• Experience with regulatory submissions (510(k), EU Tech Files)
• RAC, CQE, CPPS, CQA certifications preferred
• Understanding of continual improvement and risk management

Benefits

• Competitive benefits
• Flexible medical, life insurance, and retirement options
• Volunteer programs
• Inclusive workplace