Design Controls Manager (Medical Devices, Remote) – Global Compliance Role

Jobgether · Anywhere in the World · posted 7 months ago

All Other Remote Audit support QSR Compliance Design Controls Full-time Worldwide

We are hiring a Design Controls Manager to lead and optimize design control processes for medical device development. This remote role involves close collaboration with Regulatory, Quality, and R&D teams to ensure products meet global compliance standards while supporting efficient and timely product launches.

Key Responsibilities

Lead and improve design control processes for medical devices
Collaborate with global teams to streamline product development workflows
Ensure compliance with international regulatory standards
Conduct audits and resolve non-conformance issues
Perform gap analysis and recommend process improvements
Deliver training on design controls and quality processes
Mentor R&D and QA teams on compliance best practices
Support internal and external audits as a subject matter expert

Requirements

Bachelor’s degree in Engineering, Science, or related field (or equivalent experience)
5+ years in Quality or R&D within the medical device industry
Strong knowledge of QSR, ISO 13485, and MDSAP
Experience with QMS systems (CAPA, risk management, audits)
Proven leadership and cross-functional collaboration skills
Excellent communication and problem-solving abilities
Willingness to travel up to 25% (including international)