Regulatory Compliance Engineer
About The Position
As a Regulatory Compliance Engineer, you will be the technical expert responsible for electrical safety, electromagnetic compatibility (EMC), and regulatory compliance across our global product portfolio. Partnering with Engineering, Quality, Regulatory Affairs, and accredited testing laboratories, you'll help ensure our medical devices meet international safety standards while supporting successful product development and worldwide market access. This role offers the opportunity to influence product design from concept through commercialization by providing expert guidance on electrical safety, EMC strategy, risk management, and global regulatory compliance. Your expertise will help bring safe, high-quality medical technologies to healthcare providers around the world. This role has a hybrid work schedule – 2 days from home and 3 days in our Stafford, TX office.
Requirements
- Bachelor's degree in Electrical Engineering, Electromechanical Engineering, Quality Engineering, Regulatory Affairs, Life Sciences, or a related technical discipline.
- Minimum of 8 years of experience supporting electrical safety and EMC compliance within the medical device or life sciences industry.
- Experience working within a regulated Quality Management System (FDA 21 CFR Part 820, ISO 13485, or equivalent).
- Demonstrated expertise applying IEC 60601 standards, including electrical safety, EMC, and applicable collateral or particular standards.
- Strong knowledge of FDA regulations, ISO 13485, EU Medical Device Regulation (MDR), and global medical device compliance requirements.
- Experience developing compliance strategies, interpreting technical standards, and supporting product testing and regulatory submissions.
- Proficiency with Microsoft Office applications.
Nice To Haves
- Deep technical expertise in medical electrical safety and electromagnetic compatibility standards.
- Ability to interpret complex regulatory requirements and translate them into practical engineering solutions.
- Strong analytical, troubleshooting, and risk assessment skills.
- Excellent communication and collaboration skills with the ability to influence cross-functional teams and external partners.
- Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
- Experience leading cross-functional compliance initiatives and driving continuous improvement.
- Knowledge of ISO 14001 and environmental compliance is preferred.
Responsibilities
- Serve as the technical lead for electrical safety, EMC, and regulatory compliance across global product development programs.
- Develop electrical safety and EMC compliance strategies, including test planning, worst-case analysis, acceptance criteria, and compliance approaches.
- Interpret and apply global medical device standards and regulations, including the IEC 60601 series, FDA regulations, EU MDR, and other international requirements.
- Review and approve electrical safety and EMC test plans, protocols, and reports while partnering with accredited testing laboratories to resolve compliance challenges.
- Support global product certifications and regulatory approvals, including CE, FCC, UL, and other regional market requirements.
- Provide regulatory guidance throughout the product lifecycle, including design, verification, validation, engineering changes, product approvals, and post-market activities.
- Evaluate compliance risks, perform technical assessments, and recommend risk mitigation strategies.
- Collaborate with Engineering, Quality, Regulatory Affairs, and global teams to ensure compliance with Quality Management System (QMS) requirements, including CAPA, Change Control, Risk Management, and post-market surveillance.
- Monitor changes to global regulations and industry standards and assess their impact on current and future products.
Benefits
- Opportunity to influence product design from concept through commercialization
- Opportunity to bring safe, high-quality medical technologies to healthcare providers
- Part of a team creating medical innovations that truly make a difference
- Part of a culture that values talent as its greatest asset
- Empowering you to contribute to a mission that improves patient care worldwide
- Opportunity to solve complex engineering challenges
- Collaborate with industry experts
- Help shape the future of minimally invasive healthcare
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What This Job Offers
Job Type
Full-time
Career Level
Senior
