Regulatory Compliance Engineer

KARL STORZ SE & Co. KG; Stafford (TX); Hybrid; USD 120,000 - 155,000; Full time

Benefits offered by this job

Medical / Dental / Vision

Wellness program

3 weeks vacation

Parental leave

401(k) match

HSA

Life Insurance

Tuition reimbursement

Fitness reimbursement

Job summary

KARL STORZ North America seeks a Regulatory Compliance Engineer to lead electrical safety, EMC, and global regulatory activities across our medical device portfolio. You will partner with Engineering, Quality, and accredited labs to ensure safety standards are met from concept to market access.

The role emphasizes IEC 60601, FDA 21 CFR 820, ISO 13485, and risk management within a hybrid work model based in Stafford, TX.

Qualifications

• Bachelor's degree in Electrical Engineering or related technical field.
• Minimum 8 years of experience in electrical safety and EMC for medical devices.
• Experience with FDA 21 CFR Part 820, ISO 13485, or equivalent.

Responsibilities

• Lead electrical safety, EMC, and regulatory compliance across global product development.
• Develop test plans, risk assessments, and compliance strategies.
• Interpret IEC 60601, FDA, EU MDR and other global requirements.
• Review test plans, protocols, and reports with labs to resolve issues.
• Support global certifications and regulatory approvals (CE, FCC, UL, etc).
• Provide regulatory guidance through design, validation, and post-market activities.
• Collaborate with Engineering, Quality, Regulatory Affairs, and cross-functional teams.
• Monitor regulatory changes and assess impact on products.

Skills

Electrical safety

EMC

Regulatory affairs

Risk management

QMS

CAPA

Change control

FDA regulations

IEC 60601

Education

Bachelor's degree in Electrical Engineering or related

Job description

Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.

Get to know us and join our teamas

Regulatory Compliance Engineer

Job Function: Patient Health & Regulatory Affairs

From the operating room to surgery centers—and everywhere in between—KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging—to build a more connected, software-enabled operating room.

As an independent, family-owned MedTech company, we ambitiously think in generations instead of quarters to improve patients' lives around the world.

About the Role

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.

What You’ll Do

• 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.

What You Bring

• 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.

What Will Make You Successful

• 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.

Why KARL STORZ?

Join KARL STORZ and be part of a team creating medical innovations that truly make a difference. Beyond technology, you'll be part of a culture that values talent as its greatest asset, empowering you to contribute to a mission that improves patient care worldwide. As a global MedTech leader, you'll have the opportunity to solve complex engineering challenges, collaborate with industry experts, and help shape the future of minimally invasive healthcare.

Ready to make an impact? Apply to be our next Regulatory Compliance Engineer and help us build the future of MedTech together.

MA Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

• Medical / Dental / Vision including a state-of-the-art wellness program and access to pet insurance, too!
• 3 weeks vacation accrual for full time roles,* paid holidays plus paid sick time too
• Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
• 401(k) retirement savings plan providing a match of 66.67% (4%) of the employee’s first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• HSA Savings Accounts with company contribution
• Life, STD & LTD Insurance
• We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
• Fitness reimbursement of up to $200 annually
• And much more!

* Field sales, internships, and roles that are regularly scheduled to work less than 30 hours per week are not eligible for vacation, except where required by law. Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program. KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.

KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.