Medical Device Regulatory Affairs Strategist

Oracle is seeking a Medical Device Regulatory Affairs Strategist to drive success in the healthcare and life sciences sector. This role involves preparing product documentation for global markets, building partnerships with businesses to ensure regulatory compliance, and working directly with product engineering teams. The strategy will focus on a full lifecycle from development to post-market activities, and require collaboration across the organization.

Requirements

• BA/BS or advanced degree preferred
• Experience with SaMD in medical device industry or equivalent
• Experience with regulatory submissions (510k, EU Tech Files, etc.)
• Experience interacting with notified bodies and/or regulators preferred
• RAC, CQE, CPPS, CQA desired
• Excellent written and verbal communication skills
• Ability to adjust and adapt to changing priorities

Benefits

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