Vice President Regulatory Affairs Medical Device

Retained Search – Hybrid Position

Position Overview: The Vice President of Regulatory Affairs will be responsible for developing and leading the Regulatory strategy while providing strategic and operational leadership to the organization. In this role, you will lead and manage a team of regulatory affairs professionals, providing guidance, coaching, and performance evaluations.

Responsibilities:

• Development of Regulatory Strategies that optimize product development and registration.  
• Lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.
• Lead and manage a team of regulatory affairs professionals, providing guidance, coaching, and performance evaluations.
• Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to the management teams.
• Advises project teams regarding the development and implementation of regulatory strategy. Maintains awareness of the changing regulatory landscape and advises the team on changes that could impact future development.
• Accountable for ensuring regulatory compliance of all external materials.
• Maintain current knowledge of the global requirements and changes to applicable laws, regulations, and industry standards, and assist in disseminating this information to the appropriate individuals within the company.
• Interpret new and existing regulatory requirements related to the products and initiate actions to assure compliance with these regulations.
• Support where required internal and external audits/inspections.
• Manage the regulatory budget.
• Works with the management team to ensure all company regulatory programs achieve internal expectations.
• Ensure regulatory strategy is aligned with business needs and integrated into company goals and objectives.
• Monitor regulatory skills and capabilities as the business evolves.

Requirements:

• A minimum of 15 years of experience in a Regulatory leadership role within Class II medical devices.
• Bachelor’s degree in science or engineering.
• Experience with electro-mechanical medical devices.
• Experience with FDA remediation.
• Demonstrated track record in securing product approvals.
• Have excellent communication and presentation skills with the ability to influence and demonstrate a track record of accomplishment in presenting, interacting, and building effective relationships internally and externally.
• Expert knowledge of the FDA regulations and base knowledge of global markets.
• A detailed knowledge of Quality Management Systems and their requirements for regulatory purposes – 21 CFR 807, QSR, ISO 13485 Medical devices.
• An understanding of ISO 14971 Medical devices and the application of risk management to medical devices.

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