Medical Device Regulatory Affairs Strategist– Health & Life Sciences Legal – Health & Life Sciences Legal and Compliance Group

Oracle is seeking a Regulatory Affairs Strategist to navigate complex global regulatory landscape for AI-enabled software applications used in clinical operations. This role focuses on preparing products for market registration in various global markets, collaborating with product engineering, and ensuring compliance with regulations. The position requires a collaborative and creative problem solver with a strong understanding of regulatory frameworks and a proactive approach to change.

Requirements

• BA/BS or advanced degree preferred
• Experience with SaMD in medical device industry
• Experience with 510(k), CE Marking, Technical Files, Health Canada submissions
• RAC, CQE, CPPS, CQA (desirable)
• Experience in a quality management system (ISO 13485, 14971, 60601, 21 CFR parts 1000/1001, or 60601, 21 CFR parts 1000/1001) (desirable)

Benefits

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