Medical Device Regulatory Specialist
2 days ago
As a Medical Device Regulatory Specialist with UL Solutions, you will play a crucial role in the medical regulatory team. This position involves working independently with limited supervision to assist and support the processing of manufacturer submissions to various medical device regulations. You will be responsible for conducting audits and reviews, providing timely audit reports, and participating in the development of UL requirements and assessment methods.
Key Responsibilities
- Audit Support: Assist in the review and preparation of quality management system audits, including agenda setting, auditor training, and customer Corrective and Preventive Action analysis.
- Audit Conduct: Perform key Quality Management System audit activities, including CE, UKCA unannounced audits, under the guidance of experienced auditors.
- Reporting and Communication: Provide timely and accurate audit reports, customer responses, and communication with stakeholders.
- Team Collaboration: Work closely with cross-functional teams, including customers, internal stakeholders, and external partners.
- Travel Requirements: National and international travel may be required up to 75% of the time.
Requirements
- Education: Bachelor's degree in a relevant field, such as Science, Engineering, or Technology.
- Experience: At least four years of professional experience in healthcare products or related activities, with two years in quality management.
- Knowledge and Skills: Strong knowledge of medical device regulations, manufacturing methods, risk management, quality management systems, and auditing techniques.
- Language: English language proficiency is essential for this role.
- Authorization: Possession of active or not active medical devices codes is desirable.
Estimated Salary: $85,000 - $115,000 per annum, depending on location and experience.
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