Our start-up cardiovascular client is adding an experienced Director of Quality and Regulatory Affairs to provide hands-on leadership across quality systems and regulatory execution as the company advances its cardiovascular medical device program through clinical development and toward commercialization. This role will partner closely with R&D, Manufacturing, and Clinical teams to maintain and strengthen an established quality system, support ISO certification, and advance IDE and PMA activities.

The successful candidate will combine strong quality systems expertise with practical regulatory experience and enjoy working directly on deliverables in a lean organization. Near-term priorities include supporting planned 2026 PMA modules covering R&D, manufacturing, and preclinical information, and regulatory and quality readiness for anticipated study enrollment in early 2027.

Your role with the company:

Manage the day-to-day operation and continuous improvement of the Quality Management System, including electronic quality system administration, controlled documents, procedures, and workflows.

Lead quality system certification preparation, internal audits, management reviews, CAPA, and inspection readiness; coordinate responses and follow-up actions.

Partner with R&D and Manufacturing on design controls, risk management, verification and validation, manufacturing controls and validation master planning.

Support supplier qualification, supplier quality activities, and product quality, working collaboratively with manufacturing quality personnel.

Coordinate and prepare regulatory submission content, including IDE and PMA documentation, amendments, supplements and relevant R&D, manufacturing and preclinical modules.

Support U.S. and international clinical research submissions and ongoing regulatory commitments in partnership with Clinical and Regulatory colleagues.

Contribute to international regulatory and future CE marking activities, including Notified Body coordination and supporting technical documentation.

Work with FDA, auditors, consultants, and other external partners as needed; identify compliance risks and recommend practical solutions.

Coordinate cross-functional projects, priorities, and resources, providing quality and regulatory guidance as the company prepares for commercialization.

Desired profile:

Bachelor's degree in life sciences, engineering or a related field.

Significant medical device quality and regulatory experience, including responsibility for quality system operations and cross-functional project execution.

Experience with Class II and Class III devices; cardiovascular medical device experience preferred.

Direct experience supporting IDE and PMA submissions, including development, manufacturing or preclinical documentation; experience across the product lifecycle strongly preferred.

Strong knowledge of applicable FDA requirements, ISO 13485, design controls, risk management and medical device manufacturing quality.

Experience maintaining an established quality system and preparing for ISO certification and regulatory or quality system audits.

International experience supporting clinical research, regulatory submissions or quality compliance, ideally in Europe, Canada, Australia and New Zealand.

Experience supporting CE marking, including Notified Body interactions and preparation for initial certification.

Ability to manage electronic quality systems, controlled documentation, CAPA, supplier quality and multiple concurrent projects.

Start-up experience preferred; ability to apply sound quality practices in a resource-conscious environment.

Leadership Profile

A collaborative, detail-oriented leader who builds trust across functions, communicates clearly, and follows through on commitments. This person must be comfortable taking ownership of operational work, influencing without a large team, and balancing quality requirements with development and business priorities.