Medical Device Regulatory Affairs Strategist

Oracle is seeking a Medical Device Regulatory Affairs Strategist to join their Healthcare and Life Sciences business unit. This role involves collaborating with product engineering, subject matter experts, and cross-functional teams to navigate regulatory requirements, prepare product documentation, and ensure compliance throughout the product lifecycle. The ideal candidate will be highly collaborative, creative problem-solvers dedicated to excellence and able to thrive in a fast-paced regulatory environment.

Requirements

• BA/BS or advanced degree preferred.
• Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent.
• Experience authoring submissions (510k, EU Tech Files, etc.)
• Experience interacting with notified bodies and/or regulators preferred.
• RAC, CQE, CPPS, CQA desired
• Experience in working within a quality management system (ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001).

Benefits

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