Global Program Regulatory Director - Medical Device & IVD Excellence

Major accountabilities:

• In collaboration with multiple stakeholders, develop/document/communicate high quality global regulatory strategies and Health Authority interactions related to Medical Devices & IVDs to achieve optimal development and business objectives. 
• Evaluate and clearly communicate potential regulatory opportunities and risks for the overall program and develop mitigation strategies. 
• Leverage regional expertise on Medical Devices & and IVDs in defining and executing global regulatory strategies and Health Authorities engagement with special focus on EU and ROW. 
• Provide strategic regulatory input on key development, labeling and global promotional documents, obtaining line endorsement as appropriate. 
• Lead execution of the regulatory strategy on Medical Devices & and IVDs including submission planning, guidance to contributing authors and critical review of submission documentation including labeling and HA responses with special focus on EU and ROW. 
• Lead interactions with RA and Development Unit management and with external consultants for strategic input to regulatory strategies with special focus on EU and ROW.
• Provide strategic regulatory and development input on Medical Devices & IVDs into BD&L Due Diligence evaluations, as required.
• May serve as local HA liaison (e.g., EMA) and operationalize local regulatory strategy for Medical Devices & IVDs.

Key performance indicators:

• Creation and execution of regulatory strategy resulting in timely submission of high-quality dossiers that maximize probability of approvals
• Organizational alignment around strategy and awareness of risks and mitigations 
• High performing subteams 
• Compliance with external (e.g., Health Authority, NBOp) and internal requirements.

Minimum Requirements:
Work Experience:

• Approximately ≥8 years of regulatory and pharmaceutical development experience, ideally spanning activities in Phases I-IV. 
• Experience with regulatory strategy in most or all of the following areas: 
• Demonstrated leadership and accomplishment across a broad range of global regulatory and pharmaceutical development activities in the areas of Medical Devices, Drug/Device Combination Products and IVDs 
• Direct and matrix leadership, including demonstrated ability to provide feedback and coach subteam members 
• Strong interpersonal, communication, influencing and problem solving skills. 
• Effectively navigates organizational complexity to achieve results.

Skills:

• Deep knowledge and understanding of global regulation for Medical Devices, Drug/Device Combination Products and IVDs.
• Interpretation, feedback, guidance and application of laws and regulations.
• Interpretation and application of HA and NBOp guidance and feedback .
• HA and NBOp discussions and negotiations.
• Regulatory submissions; extensive involvement in major submissions desired.
• Post-marketing/brand optimization strategies and commercial awareness. 
• Deep understanding of Regulatory operations. 

Languages :

• Fluency in English as a business language. Additional language is an asset.