Vice President Regulatory Affairs

Vice President, Regulatory Affairs

Location: Remote

Employment Type: Full-Time, Permanent

Are you ready to join a leading, innovative, medical device company.....

We are currently searching for a seasoned professional within Medical Devices to join a leading global medical technology company specializing in the development of innovative healthcare solutions and devices.

The VP of Regulatory Affairs leads a team responsible for obtaining and maintaining approvals for diverse products across global Operating Units. This includes various items like implantable systems, combination products, controllers, and cloud-based services. The role necessitates regulatory expertise, technical knowledge, and leadership to manage approvals and build global relationships with internal and external partners.

Responsibilities:

• Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities.
• Head a skilled, diverse regulatory affairs team adept at navigating global regulations.
• Collaborate across the organization to enhance regulatory workflows.
• Devise and execute strategies for prompt global product launch while adhering to regulations.
• Offer strategic regulatory counsel to senior management.
• Cultivate enduring connections with worldwide regulatory counterparts and authorities.
• Assure comprehensive and lawful post-launch product backing.
• Showcase capacity to apply cross-therapy insights for approvals and compliance.
• Institute and sustain internal controls for mandated regulatory compliance.

Requirements:

• You must have at least 15 years of managerial experience in the medical devices sector.
• Extensive regulatory knowledge & experience across a variety of product classifications, with a strong background of Class III PMA & Class III EU.
• A bachelor's degree in a scientific or technical discipline.

Get in touch today to find out more!

📞 267-669-1067

📧 [email protected]