What are the responsibilities and job description for the Senior Regulatory Compliance Engineer - Medical Devices & Global Standards position at VDart, Inc.?
Job Details
Job Title: Senior Regulatory Compliance Engineer - Medical Devices & Global Standards
Location: Waukesha WI (onsite)
Duration/Term: Long Term Contract
Job Summary
The team developing industry-leading X-ray generation subsystems seeks motivated regulatory engineers to ensure compliance and availability of these subsystems for CT scanners across global markets. This role involves managing compliance with medical device regulations, updating documentation, supporting audits, and aligning with quality management systems to maintain regulatory standards.
Key Responsibilities
- Cross-Functional Collaboration: Work with engineering, manufacturing, regulatory, sourcing, and other teams to support compliance activities for medical device regulations.
- Regulatory Compliance Monitoring: Review compliance change notifications and implement actions to meet regulatory requirements by the effective date.
- Global Regulation Management: Lead compliance efforts for various global regulations, such as REACH, ROHS, and align with quality management systems.
- Documentation Management: Create and update product regulatory documents, including NRTL reports, tech files, and related documentation.
- Audit & Inspection Support: Assist in regulatory audits and inspections, ensuring adherence to post-market surveillance compliance
Qualifications
Minimum Qualifications
- Medical Regulations Expertise: Knowledge of global medical regulations, including FDA, EU MDR, NMPA/CFDA, and others.
- Standards Knowledge: Proficiency in regulatory standards, such as IEC 60601, ISO13485, ISO14971, and applicable sub-standards.
- Technical Proficiency: Ability to interpret and apply complex regulations while preparing associated documentation.
- Education: Bachelor s degree in Engineering, Science, or a related area.
- Experience: 10 years of experience in regulatory engineering, compliance, or quality assurance for medical devices.
- Communication Skills: Excellent interpersonal skills, written English proficiency, and a neutral English accent.
Preferred Qualifications
- Technical Knowledge: Strong expertise in medical devices and regulatory practices.
- Analytical Skills: Effective probing and analytical abilities for understanding and resolving compliance challenges.
- Attention to Detail: Demonstrated ability to maintain precision in documentation and regulatory assessments.
Key Competencies
- Regulatory Leadership: Proactively manage and implement compliance strategies for global regulations.
- Problem Solving: Identify regulatory challenges and propose effective solutions.
- Collaboration: Engage with diverse teams to ensure compliance across functional areas.
Key Skills
Medical Device Regulations (FDA, EU MDR, NMPA/CFDA), IEC 60601, ISO13485, ISO14971, REACH/ROHS Compliance, Regulatory Documentation (NRTL Reports, Tech Files), Post-Market Surveillance, Regulatory Audits and Inspections, Effective Communication, Attention to Detail, Technical Knowledge.
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