Title: Medical Device Regulatory Specialist
Duration: 11 Months
Location: Remote (Base Location: Wauwatosa, WI)
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.
High attention to detail.