Director, Regulatory Affairs (Hybrid)

About Spectrum Vascular Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades.

Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. Role Description: The Director, Regulatory Affairs is responsible for leading and executing regulatory activities to support global product registrations and lifecycle compliance for the company’s medical device portfolio.

, 510(k)s), regulatory assessments, and agency interactions.

Requirements

are effectively translated into actionable plans and deliverables across the product lifecycle.

, guidance documents, and regulatory intelligence, translating them into actionable plans. Provide expert regulatory input into design control, risk management (ISO 14971), clinical, and preclinical activities to support submissions and compliance. Assess the regulatory impact of product and process changes, and define appropriate submission strategies or justification for non-submission.

Lead and support regulatory agency interactions, including pre-submissions, deficiency responses, and meeting preparation. Ensure timely responses to regulatory inquiries and manage commitments to regulatory bodies. Oversee and contribute to labeling and promotional material review to ensure compliance with applicable regulations and approved claims.

Provide regulatory leadership in quality system activities, including CAPAs, nonconformances, field actions, and change control. Support and participate in audits and inspections (FDA, Notified Bodies), including preparation and response activities. Mentor and provide guidance to junior regulatory staff, while remaining actively engaged in execution.

Contribute to the development and continuous improvement of regulatory processes, SOPs, and internal best practices.

Key Responsibilities

Serve as the regulatory lead for product development and lifecycle management, providing both strategic direction and hands-on execution of regulatory deliverables. , 510(k), PMA, international dossiers), ensuring high-quality, technically sound, and compliant submissions. S.

FDA and global regulatory submissions, including direct interaction with regulatory authorities and notified bodies. Drive regulatory strategy development for new products, product changes, and global market expansion, while ensuring alignment with business objectives. Act as the primary regulatory representative on cross-functional teams, influencing decisions related to product design, claims, testing, and labeling.