Job Description

The Vice President of Regulatory and Quality plays a crucial role in ensuring compliance with regulatory standards and maintaining the highest levels of quality within the organization. This executive-level position requires a deep understanding of regulatory requirements, quality management systems, and a strategic mindset to drive continuous improvement initiatives. The Vice President of Regulatory and Quality oversees all aspects of regulatory affairs, quality management systems, and quality assurance to uphold product integrity and meet regulatory obligations.

Responsibilities

• Ensure regulatory compliance
• Develop and maintain quality management systems
• Lead Design Control program
• Develop and implement post-market surveillance strategies
• Identify and assess regulatory and quality risks
• Recruit, develop, and retain a high-performing team
• Provide strategic regulatory/quality guidance
• Collaborate with cross-functional teams
• Drive continuous improvement initiatives

Requirements

• Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred
• Extensive experience in regulatory affairs and quality management within the medical device, biotechnology, or related industries
• Proven track record of successful regulatory submissions, quality audits, and continuous improvement initiatives
• In-depth knowledge of regulatory requirements, standards, and guidelines
• Strong understanding of quality management systems, including GMP, GCP, and ISO standards
• Excellent leadership, communication, and interpersonal skills
• Strategic mindset with the ability to drive change and foster innovation
• Thrives in a fast-paced, hands-on environment that is frequently changing
• Excellent written and verbal communication skills
• Exceptional problem-solving and decision-making abilities
• Demonstrated experience in building, leading, and developing high-functional teams

Benefits

• No benefits