The client is seeking a strategic regulatory leader to oversee global regulatory affairs and labeling strategy within the medical device industry. This leadership position involves shaping regulatory direction at the executive level, driving product approvals, and managing lifecycle and compliance initiatives. Key responsibilities include defining global regulatory strategy, providing guidance for new product launches, and ensuring alignment with evolving regulatory standards. The Director will act as the primary liaison with global regulatory authorities, direct major submissions, and champion compliance programs, while guiding cross-functional teams across various departments.
Ideal candidates will have over 10 years of progressive experience in regulatory affairs for medical devices, strong global labeling oversight, and a background in global regulatory submissions. Experience with complex technologies and interaction with regulatory agencies in the U.S. and internationally is important. Candidates should have at least 5 years of leadership experience, focusing on managing senior professionals. Preferred qualifications include experience with sterile disposables, electro-mechanical devices, and drug/device combination products. Regulatory certifications such as RAC are advantageous, as is a strong foundation in Quality Management Systems.
Successful candidates will demonstrate executive-level strategic thinking, the ability to interpret complex regulations for practical application, and confidence in representing innovative technologies to regulatory bodies. Influence skills across senior leadership, the ability to develop a high-performing regulatory team, and a commitment to building a culture of regulatory excellence is crucial. The role may require creative and proactive strategies in navigating regulatory pathways and emphasizes engagement with industry trends and proactive risk management. The position offers a chance to make a significant impact on compliance and regulatory strategy in a dynamic and innovative setting.