Location: Hybrid (Illinois, US).
Citizenship Requirement: U.S. Citizenship
Please read the job description thoroughly, this is not a standard regulatory specialist role and we are looking for a specialized skillset.
Job Summary
- Hands-on expert responsible for ensuring product compliance with evolving global technical requirements and regulations.
Duties/Responsibilities
- Maintain in-depth knowledge of all technical regulations and guidance relevant to medical device equipment and disposable products. Regulations include IEC-60601 standards and its subsidiaries; ISO-14971; UL and TUV requirements for medical devices; IEC electrical standards; applicable ASTM standards and test methods, and the evolving FDA and European software requirements.
- Actively monitor trends and changes in global medical device technical regulations.
- Continuously assess and ensure compliance of equipment and disposables as standards and products evolve.
- Review design changes for compliance with technical standards during the development process.
- Identify compliance gaps in technical standards and lead timely corrective actions to update products and documentation, through hands-on work or by guiding others.
- Conduct product testing, develop test protocols, perform tests, and manage external test labs and regulatory interactions.
- Update, enhance, and maintain product technical documentation, including requirements, usability testing, verification protocols, and trace matrices.
- Provide technical input on product changes required for compliance, assisting design engineers as needed.
- Lead the development of efficient internal processes and tools for creating and managing technical documentation, including automating trace matrix linkages.
- Educate staff on relevant technical regulations.
Job Requirements
Education and Experience
- Technical degree, BS minimum, preferably in Electrical or Software Engineering.
- Minimum 8 years of experience in test engineering or equivalent.
Required Skills/Abilities
- Demonstrated expertise in medical device standards and regulations.
- Proven ability to develop test protocols and perform electrical, system, and software tests.
- Experience at a test laboratory is preferred.
- Proficiency in spreadsheets; experience with statistical tools like MiniTab is preferred.
- Strong communication skills, both verbal and written.
Location and Remote Work
- Majority of work is on-site, with some remote flexibility.
- Occasional domestic travel, typically less than 10%.
Job Classification and Reporting
- Full-time, salaried exempt.
- Reports to the Managing Director of Operations and R&D.