Director, Regulatory Affairs

Spectrum Vascular

Director of Regulatory Affairs at Spectrum Vascular leading regulatory activities for medical device registrations. Oversee submissions and ensure compliance with FDA and global regulations.

Posted 4/28/2026full-timeWarren • New Jersey • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

Serve as the regulatory lead for product development and lifecycle management, providing both strategic direction and hands-on execution of regulatory deliverables.
Author, review, and finalize regulatory submissions (e.g., 510(k), PMA, international dossiers), ensuring high-quality, technically sound, and compliant submissions.
Lead preparation and management of U.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.
Evaluate and interpret regulatory requirements, 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.

Requirements

What you’ll need

Bachelor’s degree (B.S. or B.A.) in Engineering, Life Sciences, or related field required
8–10+ years of regulatory affairs experience in an FDA-regulated industry (medical device preferred)
Demonstrated hands-on experience authoring and leading 510(k) submissions
Strong knowledge of FDA regulations, global regulatory frameworks, and medical device requirements
Experience interacting directly with FDA and Notified Bodies
Solid understanding of design controls, product development, and lifecycle management
Advanced degree preferred

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissions510(k)PMAregulatory strategy developmentdesign controlrisk managementclinical activitiespreclinical activitieslabeling complianceSOP development

Soft Skills

leadershipmentoringcommunicationinfluencingstrategic directioncollaborationproblem-solvingorganizational skillsattention to detailadaptability