This position has the responsibility for developing and implementing global medical device regulatory strategy. S/he is also responsible for addressing and resolving regulatory issues in preclinical, manufacturing, clinical and commercial development programs. The position interacts with all levels in the organization, participating in discussions with management and providing strategic regulatory guidance.

What will you do?

Provide Strategic Regulatory Guidance to Management and Inter-disciplinary Project Teams

• Serve as lead regulatory representative to provide effective regulatory leadership to project team and clinical development teams for clinical stage products.
• Strong knowledge of FDA, EU, TGA, cGMP and ISO 13485 requirements to ensure compliance with regulatory requirements for manufacturing, design control and clinical development activities.
• Develop and implement global regulatory strategies and plans for projects at different phases of development.
• Provide regulatory review and approve internal documents supporting project team and clinical development activities.
• Lead and manage the development and preparation regulatory submission documents to support the filing and maintenance of IDE, PMA, 510k, MDR applications, etc.    
• Apply expert strategic and scientific regulatory knowledge of product development to ensure compliance with global filing requirements.
• Interact and coordinate with project team staff to ensure compliance to applicable Design Control requirements for medical device products.

Prepare and File High-Quality Submissions to Regulatory Authorities

• Oversee the compilation and preparation of high-quality submissions to regulatory authorities (e.g., briefing books, 510k, IDE, PMA, amendments, supplements, annual reports, etc.) ensuring all regulatory requirements are met.
• Prepare driver reports for submission deliverables and follow-up with team members, ensuring that all
• applications are filed in accordance with predetermined timelines.
• Proactively identify regulatory, quality and technical issues and recommend and/or implement solutions to resolve them.
• Maintain accurate and timely regulatory records and logs.

Interact and Negotiate with Regulatory Agencies, Primarily US & EU, Regarding Strategy and Resolution of Complex Issues

• Manage resolution and responses to queries from regulatory agencies (FDA and OUS).
• Management of medical device import & export processes.
• Participate in regulatory meetings with Competent Authorities

Manage and Prioritize Assigned Projects in Accordance with Department and Company Goals

• Assist in managing and prioritizing the team's workload in accordance with departmental goals.
• Ensure that multi-disciplinary project teams work effectively and productively and have proper coordination.
• Stay Abreast of US & International Regulatory Initiatives; Continually Innovate and Adapt Practices to Ensure Best Practices
• Stay current on new regulatory or other industry initiatives that could have a significant impact on the company’s current or development products.
• Share best practices for planning, organization and time management.
• Gain deep insight into the medical device industry by actively participating in professional organizations.
• Ensure that department management is aware of team activities and progress.
• Develop staff and conduct quarterly check-in reviews, as applicable.
• Perform other duties as assigned.

• A Bachelor’s Degree (minimum) in a scientific discipline from an accredited university is required.
• Minimum of 10 years of regulatory or related experience
• A minimum of 10 years’ experience in medical device  development with 5 years’ experience in US regulatory development
• A minimum of 3 years of supervisory experience
• Hands-on experience in preparing FDA, EU, and OUS premarket submission applications, including but not limited to IDE’s, 510 (k)’s, PMA, EU MDR’s product registration, etc.
• Solid experience of regulatory system in a FDA regulated environment, including compliance aspects.