Product Compliance Specialist

Product Compliance Specialist

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Varian Medical Systems, a Siemens Healthineers company is seeking an onsite Product Compliance Specialist at our Headquarters in Palo Alto, California. This role will allow some remote/hybrid flexibility but the successful applicant should be prepared to be onsite several days per week.

The Product Compliance Specialist is responsible for ensuring global product compliance and certification throughout the product lifecycle, from concept and development through commercialization and obsolescence. This role serves as the subject matter expert for product safety, EMC, and applicable regulatory standards, partnering closely with Engineering, Quality, Regulatory Affairs, and external certification agencies to maintain compliance for medical device products.

The Product Compliance Specialist provides technical guidance on safety and EMC requirements, supports risk management activities, coordinates regulatory and certification testing, and ensures products meet applicable global standards and regulatory requirements.

Product Safety & EMC Compliance

• Determine applicable regulatory requirements and standards for new and existing products.
• Provide product safety and EMC guidance based on standards expertise, interpretation, and research.
• Support safety and EMC investigations throughout the product lifecycle.
• Communicate compliance requirements and design considerations to cross-functional and hardware engineering teams.
• Participate in risk management reviews and product safety assessments.
• Support compliance activities from product development through end-of-life.

Regulatory & Certification Management

• Coordinate testing activities with third-party laboratories and certification bodies.
• Support global product approvals and ongoing certification maintenance.
• Assist with regulatory agency inspections and quarterly Follow-Up Services (FUS) activities.
• Maintain compliance records, certifications, and technical documentation.
• Ensure continued compliance with applicable global regulatory and industry standards.

Cross-Functional Partnership

• Work closely with Engineering, Quality, Regulatory Affairs, and Product Management teams.
• Communicate compliance status, test results, and certification updates throughout all design phases.
• Provide technical recommendations related to product safety, EMC, and certification requirements.
• Support issue resolution related to product compliance and certification activities.

Standards & Technical Expertise

• Apply expertise in medical electrical safety and EMC standards to support product development efforts.
• Interpret standards requirements and translate them into actionable technical requirements.
• Support compliance strategies for new product introductions and design changes.
• Assist with investigations related to EMC, EMI, and product safety concerns.

Required Qualifications

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related technical discipline.
• 5+ years of experience in product compliance, EMC, electrical safety, or related compliance functions.
• Experience managing product compliance activities and obtaining global certifications.
• Experience working with medical electrical safety and EMC standards, including: IEC 60601-1 IEC 60601-1-2 IEC 60601-2-1
• Proven experience obtaining NRTL approvals for medical devices.
• Knowledge of electronics, mechanical design, and product safety principles.
• Experience working with third-party testing and certification laboratories.
• Experience developing and documenting technical requirements based on regulatory and industry standards.
• Proficiency with Microsoft Office applications, including Excel.

Preferred Qualifications

• Master's degree in Electrical Engineering, Mechanical Engineering, or related technical field.
• Experience troubleshooting EMC/EMI hardware issues.
• Experience with FDA guidance and regulatory requirements for medical devices.
• Knowledge of laser safety requirements and compliance standards.
• Experience conducting medical device safety risk assessments.
• Strong analytical and problem-solving skills, including statistical analysis.
• Excellent communication and cross-functional collaboration skills.

Additional Information

• Based in Palo Alto, California.
• Hybrid work environment with onsite collaboration required several days per week.
• Approximately 10% international travel as needed.
• Opportunity to support innovative medical technologies as part of Varian, a Siemens Healthineers company.