Strategic Regulatory Affairs Director, Medical Devices

Gateway Recruiting; Boston (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Gateway Recruiting is seeking an Associate Director for Regulatory Affairs located in Boston, Massachusetts. This role involves managing regulatory professionals and ensuring compliance with FDA and international regulations while supporting product submissions.

The candidate should have 5-7 years of experience in regulatory affairs and a Bachelor’s degree. Preferred qualifications include advanced degrees in relevant fields and certifications in regulatory affairs. This on-site position requires strong leadership and strategic planning skills.

Qualifications

• 5-7 years of experience in a regulated industry (e.g., medical products).
• Experience in regulatory, quality assurance or related areas.
• Higher education may compensate for years of experience.

Responsibilities

• Set strategy for submissions to regulatory agencies.
• Provide guidance on regulatory requirements for product development.
• Maintain expert knowledge of laws related to Quality Assurance and R&D.

Skills

Regulatory requirements

Scientific knowledge

Quality Assurance

Project management

Regulatory compliance

Team leadership

Education

Bachelor’s Degree

M.S. or M.B.A.

Tools

Regulatory submission software

Job description

Gateway Recruiting is seeking an Associate Director for Regulatory Affairs located in Boston, Massachusetts. This role involves managing regulatory professionals and ensuring compliance with FDA and international regulations while supporting product submissions.

The candidate should have 5-7 years of experience in regulatory affairs and a Bachelor’s degree. Preferred qualifications include advanced degrees in relevant fields and certifications in regulatory affairs. This on-site position requires strong leadership and strategic planning skills.