VP Regulatory Affairs and Compliance

The ideal candidate will bring a deep understanding of global regulatory environments, hands-on experience managing Quality Management Systems (QMS), and a proactive approach to compliance. You will work closely with cross-functional teams, regulatory authorities, and executive leadership to navigate complex regulatory landscapes, ensure the success of product launches, and maintain reputation for innovation and quality.

Key Responsibilities

Regulatory Affairs

• Develop and execute regulatory strategies to support the global launch and approval of the company's products.
• Lead interactions with regulatory authorities to secure and maintain required certifications and approvals.
• Ensure compliance with applicable standards for both existing and emerging markets.
• Provide strategic input during product development to ensure regulatory requirements are met throughout the lifecycle.

Compliance Oversight

• Establish, implement, and oversee a comprehensive compliance framework, addressing local, national, and international regulatory requirements.
• Lead the implementation and maintenance of the company’s Quality Management System (QMS) in accordance with global standards (e.g., ISO 13485, 21 CFR).
• Define, oversee, and continuously improve quality processes and procedures, including document control, corrective and preventive actions (CAPA), risk management, and supplier quality management.
• Monitor changes in regulatory environments and proactively update policies, processes, and the QMS to maintain compliance.
• Ensure marketing, labeling, and promotional activities align with regulatory and quality guidelines.
• Develop risk management strategies and ensure robust reporting mechanisms for compliance and quality issues.
• Oversee the review and approval of all product quality documentation, including validation protocols, risk assessments, and quality reports.
• Conduct internal and supplier audits to ensure adherence to quality and compliance standards, identifying and addressing gaps proactively.

Leadership & Collaboration

• Serve as the primary advisor to executive leadership on regulatory, compliance, and quality matters.
• Build and manage a high-performing regulatory, compliance, and quality team.
• Educate employees and foster a culture of compliance and quality through training programs and ongoing communication.

Requirments:

• Advanced degree in a relevant field (e.g., Regulatory Science, Law, Life Sciences, or equivalent).
• Minimum of 10 years of experience in regulatory affairs, compliance, and quality management, at least 6 of which in the medical device sector.
• Proven success in securing regulatory approvals and maintaining QMS compliance across multiple geographies.
• Strong understanding of global regulatory frameworks and quality standards.
• Exceptional strategic thinking and problem-solving skills.
• Strong interpersonal and communication abilities to navigate complex regulatory and quality landscapes.
• Demonstrated leadership experience in building and managing diverse teams.
• Proactive, detail-oriented, and highly organized with a results-driven mindset.