Medical Device Regulatory Affairs Strategist

Oracle is seeking a Medical Device Regulatory Affairs Strategist to drive the success of its AI-enabled healthcare and life sciences business. This role involves navigating complex regulatory landscapes, ensuring product registration in global markets, and establishing partnerships with stakeholders to comply with regulatory requirements. The strategist will focus on post-market surveillance, audits, and maintaining market authorization to support product launch and post-market activities.

Requirements

• BA/BS or advanced degree preferred
• Experience with SaMD in medical device or equivalent
• Experience authoring submissions (510k, EU Tech Files, etc.)
• Experience interacting with notified bodies and/or regulators
• Ability to perform in a fast-paced environment
• RAC, CQE, CPPS, CQA desired
• Experience working within a quality management system (ISO 13485, ISO 14971, etc.)

Benefits

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