What are the responsibilities and job description for the Medical Device Regulatory Compliance Specialist position at Medix™?
At Medix™, we are seeking a highly skilled Medical Device Regulatory Compliance Specialist to join our team. This role will play a vital part in supporting the implementation and compliance of the Unique Device Identification (UDI) program within the medical device industry.
The successful candidate will collaborate closely with various departments, including Regulatory Affairs, Supply Chain, R&D, QA, and Marketing, to ensure accurate data management and adherence to FDA and global regulations.
- Collect, verify, and enter UDI data into internal and external databases.
- Evaluate and maintain data accuracy between labels and master UDI data.
- Assist in implementing UDI-compliant solutions and updating Standard Operating Procedures (SOPs).
- Support process improvements for regulatory data accuracy.
- Provide training on UDI and GUDID requirements.
To be successful in this role, you should possess:
- A minimum of 1 year of experience in UDI within the medical devices sector.
- Familiarity with Enterprise Resource Planning (ERP) systems such as SAP or Oracle.
- A Bachelor's degree in a life science-related field.
- Strong attention to detail, communication, and organizational skills.
