Regulatory Affairs Director - Medical Devices & Compliance

Spectrum Staffing Services; East Hanover (NJ); Vor Ort; USD 150.000 - 230.000; Vollzeit

Benefits dieser Stelle

Leadership exposure

Senior leadership collaboration

Cross-border regulatory exposure

Mentorship opportunities

Zusammenfassung

Spectrum Staffing Services seeks an experienced regulatory affairs leader to guide approvals, quality system compliance, and corporate regulatory programs across the U.S. and Canada for Class II/III medical devices and human cell and tissue-based products.

This full-time leadership role partners with quality, medical, and executive teams. You will oversee regulatory strategy, submissions (PMAs, 510(k)s, supplements), registrations, quality oversight under 21 CFR Part 820 and ISO 13485, audits,

Qualifikationen

• Senior regulatory leadership with deep knowledge of FDA/Canada medical device regulations.
• Experience delivering regulatory submissions and managing quality systems programs.

Aufgaben

• Lead regulatory planning and submissions for PMAs, 510(k)s, supplements, and other requests.
• Maintain U.S. and Canadian device registrations and listings; manage renewals and related compliance.
• Oversee quality system oversight under 21 CFR Part 820 and ISO 13485; manage procedures and quality agreements.
• Direct medical device reporting, complaints, and CAPAs; support audits and investigations.
• Serve as primary regulatory contact for leadership, consultants, and regulatory authorities.
• Guide corporate compliance practices and labeling/training materials for regulatory accuracy.
• Develop and update policies, procedures, and technical records; support inspections and audits.
• Provide guidance and training to employees; supervise regulatory and quality personnel.

Kenntnisse

Regulatory leadership

Regulatory strategy

FDA knowledge

Quality systems

Cross-functional leadership

Technical writing

Ausbildung

Bachelor's degree in science/healthcare

RAC certification

Tools

QMS software (TrackWise)

Jobbeschreibung

Spectrum Staffing Services seeks an experienced regulatory affairs leader to guide approvals, quality system compliance, and corporate regulatory programs across the U.S. and Canada for Class II/III medical devices and human cell and tissue-based products.

This full-time leadership role partners with quality, medical, and executive teams. You will oversee regulatory strategy, submissions (PMAs, 510(k)s, supplements), registrations, quality oversight under 21 CFR Part 820 and ISO 13485, audits,