Freelance Consultant - Software as a Medical Device (SaMD)
We're looking for an experienced freelance consultant to support regulatory and quality activities across a range of complex medical devices. This role suits someone who has worked with life‑sustaining, electromechanical, infusion, monitoring, renal, or surgical technologies and understands the demands of global compliance.
What You'll Do
- Develop regulatory and compliance strategies for diverse medical devices, including infusion/drug‑delivery systems, monitoring devices, renal therapies, surgical technologies, and combination products.
- Review design documentation, risk management files, V&V evidence, and usability records to ensure alignment with FDA, ISO 13485, ISO 14971, and device‑specific standards.
- Advise on quality system processes such as design controls, supplier management, change control, and post‑market requirements.
- Support preparation of global submissions (e.g., 510(k), PMA, MDR technical documentation).
- Conduct gap analyses to identify compliance risks and improvement opportunities.
- Work with cross‑functional teams to ensure regulatory expectations are integrated throughout development and manufacturing.
- Assist with regulatory communication, audit prep, and responses to authorities.
What We're Looking For
- 5+ years in regulatory, QA, engineering, or similar roles in the medical device sector.
- Experience with high‑complexity or high‑risk devices (infusion, renal therapy, monitoring, surgical, or similar).
- Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and relevant product standards.
- Demonstrated success supporting products through development, approval, and post‑market stages.
- Ability to operate independently as a freelance consultant and manage multiple clients or projects.
FAQs
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