The Vice President of Global Regulatory will lead the Regulatory Affairs team to establish and maintain systems and processes in compliance with the Food and Drug Administration (FDA) and international regulations
*Manage the regulatory submission process by collaborating and coordinating with relevant individuals and/or groups.
*Oversee monitoring and compliance of all regulatory submissions and renewals;
*Develop regulatory strategies and plans to ensure alignment with their business strategy. Direct and lead regulatory staff in the execution of strategy and regulatory submissions;
*Manage all communication with FDA and act as the key contact with external auditors and FDA investigators.
*Responsible for developing in the development of the technical requirements of supply and Quality agreements and other external contracts.
*Has direct management responsibility for the staff and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity and businesses processes in place to maximize compliance and business responsibilities. Ability to develop and foster an effective team environment.
*Develop and maintain product registrations
*Bachelor’s degree in related science or technical engineering discipline.
*10+ years of progressive Regulatory Affairs experience in the medical device industry.
*Experience with EU and OUS submissions.
*Willing to travel 30% – 60%, or as required
*Strong people management skills and ability to work cross functionally.
*Excellent working knowledge of regulatory requirements for FDA registration.
*Experience registering medical devices in Europe, Asia, and Latin America.
*Demonstrated success in effectively leading a quality organization, including a history of building a cohesive organization working collaboratively across all parts of the organization.
Job Reference: MS-MD-075
$150,000 - 180,000