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Medical Device Industry Biomedical Engineer Quality Engineering Regulatory Compliance Specialist

Medical Device Regulatory Specialist - MDRS

Job in Milwaukee, Milwaukee County, Wisconsin, 53244, USA
Listing for: NavitsPartners
Full Time position
Listed on 2025-04-23
Job specializations:
  • Engineering
    Medical Device Industry, Biomedical Engineer, Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 35 USD Hourly USD 35.00 HOUR
Job Description & How to Apply Below
Position: Medical Device Regulatory Specialist - MDRS 25-21832

Title : Medical Device Regulatory Specialist

Duration : 11 Months

Rate : $35 / hour (W2)

Job Description :

A leading medical technology team is seeking highly motivated Regulatory Engineers to join efforts in ensuring global compliance and availability of advanced X-ray generation subsystems for CT scanners. This role focuses on regulatory compliance activities for various medical device regulations across global markets.

Key Responsibilities :

  • Collaborate with cross-functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance efforts with medical device regulations.
  • Review regulatory compliance change notifications and take necessary actions to ensure timely adherence.
  • Lead compliance initiatives related to global regulations (e.g., REACH, RoHS) in accordance with quality management systems.
  • Maintain and update product regulatory documentation (e.g., NRTL reports, technical files).
  • Support regulatory audits and inspections, contributing to post-market surveillance compliance.

    • Minimum Qualifications :

  • Strong understanding of medical device regulations, including FDA, EU MDR, NMPA / CFDA, and other international standards.
  • Familiarity with regulatory standards such as IEC 60601, ISO 13485, ISO 14971, and related sub-standards.
  • Ability to interpret and apply complex regulations and prepare corresponding documentation.
  • Excellent interpersonal communication and collaboration skills.
  • Bachelor's degree in Engineering, Science, or a related field.
  • Minimum of 2 years’ experience in medical device regulatory affairs and quality management systems.
  • Proficiency in written English and the ability to communicate with a neutral English accent.

    • Preferred Qualifications :

  • Strong technical background.
  • Excellent analytical and problem-solving skills.
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