Quality Systems & Regulatory Affairs Director

About the Company:

The Director of Quality Systems and Regulatory Affairs will be responsible for ensuring compliance with regulatory requirements, maintaining robust quality management systems, and guiding product development processes across the organization. This role requires a strategic leader who can navigate complex regulations and drive a culture of quality excellence.

About the Role:

This role requires a strategic leader who can navigate complex regulations and drive a culture of quality excellence.

Responsibilities:

• Develop and implement quality and regulatory strategies aligned with corporate objectives and regulatory requirements.
• Lead and mentor the Quality Systems and Regulatory Affairs team, fostering a culture of compliance, continuous improvement, and accountability.
• Serve as the primary point of contact for all regulatory agencies and manage communications regarding submissions, inspections, and inquiries.
• Prepare and submit necessary regulatory filings (e.g., 510(k), PMA, CE Mark) to obtain and maintain product approvals across global markets.
• Oversee the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA regulations, and other relevant standards.
• Conduct regular audits and inspections to ensure compliance with quality system requirements and proactively address non-conformities.
• Lead risk management activities throughout the product lifecycle, including risk assessments, mitigation strategies, and post-market surveillance.
• Ensure that product-related complaints are investigated and resolved in a timely manner, with appropriate reporting to regulatory authorities.
• Develop and execute training programs for employees regarding quality standards, regulatory requirements, and best practices.
• Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure compliance throughout all phases of product development and commercialization.
• Drive initiatives for continuous improvement in quality processes, metrics, and product quality outcomes.
• Analyze data to identify trends, make informed decisions, and generate reports for leadership review.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field; Master’s degree preferred.
• A minimum of 10 years experience in Quality Assurance and Regulatory Affairs within the medical device industry.
• In-depth knowledge of FDA regulations, ISO standards, and other international regulatory requirements applicable to medical devices.
• Proven experience in leading regulatory submissions and quality system audits.
• Strong leadership, communication, and interpersonal skills.
• Ability to work collaboratively in a team-oriented environment and manage multiple projects simultaneously.
• Demonstrated ability to influence across functions and lead through collaboration rather than direct authority.
• Strong analytical, communication, and leadership skills.
• Experience supporting senior leadership and driving business performance through financial insights.