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

Oracle is seeking a Medical Device Regulatory Affairs Strategist to drive the success of their healthcare and life sciences business. This role involves preparing documentation for global markets, establishing partnerships with businesses, and ensuring compliance with regulatory requirements. The ideal candidate will be collaborative, creative, and dedicated to excellence in a fast-paced environment.

Requirements

• Work closely with Oracle’s product engineering teams to assess product functionality.
• Collaborate cross-functionally with other teams to create and manage pre-market submissions.
• Maintain documentation and post market surveillance report to maintain market authorization.
• Review and recommend changes to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures.
• Manage and compliance related projects for Health-related products.
• Conduct and facilitate internal and external audits.

Benefits

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