Medical Device Regulatory Affairs Strategist

About the role

At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe.

Responsibilities

• Work closely with Oracle’s product engineering teams to assess product functionality and develop regulatory strategy.
• Collaborate cross-functionally with other teams to create and manage pre-market submissions (including 510(k), CE Marking under EU MDR, Technical Files, applications to Health Canada, and other global submissions) across global markets ensuring compliance with regulatory authorities.
• Maintain documentation and post market surveillance report on an ongoing basis to maintain market authorization.
• Serve as a subject matter expert for internal clients with interpretation of applicable standards and regulations, and use of the quality management system.
• Manage and compliance related projects for Health-related products.
• Review and recommend changes to labeling, marketing communications, clinical protocols, design processes, and manufacturing procedures to maintain regulatory and quality compliance.
• Manage compliance with changing regulatory requirements across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs.

Qualifications

• 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.) required.
• Experience with sustaining and new product development is ideal.
• Experience interacting with notified bodies and/or regulators preferred.
• RAC, CQE, CPPS, CQA desired.
• Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 21 CFR parts 1000/1001, or Quality System Regulations.
• Understands continual improvement and risk management.
• Excellent written and verbal communication skills.
• Ability to adjust and adapt to changing priorities in a dynamic environment.
• Ability to perform in a fast-paced and continually evolving business environment.