The Senior Regulatory & Quality Specialist will support and strengthen our compliance activities within an FDA‑regulated and ISO‑certified medical device environment
Job Summary
The Senior Regulatory & Quality Specialist will support and strengthen our compliance activities within an FDA‑regulated and ISO‑certified medical device environment.
This role is responsible for ensuring adherence to FDA, ISO and related global regulatory requirements.
We offer a supportive culture in a growing and dynamic work environment.
Matching Summary
The Senior Regulatory & Quality Specialist will support and strengthen our compliance activities within an FDA‑regulated and ISO‑certified medical device environment.
Skills & Requirements
Must-have
FDA regulated medical device environment
ISO certified medical device environment
Regulatory submissions
Quality system management
Document control
Post-market compliance
Nice-to-have
Diverse and inclusive workplace
Collaborate cross-functionally
Supportive culture
Growing and dynamic work environment
Key Requirements
Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related field
5+ years of experience in medical device regulatory or quality roles
Hands-on experience with FDA and ISO requirements
Experience preparing regulatory submissions such as 510(k)