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Regulatory Compliance Coordinator
2 months ago
Position Overview: Join Bio Source Ltd, a Logik Source company, as a Regulatory Manager, where you will play a pivotal role in ensuring compliance within the MedTech sector, particularly focusing on IoT medical wearable technology.
Key Responsibilities:
- Conduct internal and regulatory audits, ensuring adherence to standards such as ATEX, FDA, and CE Medical Devices.
- Oversee the management of technical documentation and files related to regulatory submissions.
Qualifications:
The ideal candidate will possess:
- A robust background in Medical Regulatory Approvals, specifically within BioTech or MedTech industries.
- Experience in managing internal and regulatory audits.
- Familiarity with ATEX, FDA, and CE Medical Devices.
Work Arrangement: This role offers flexibility, with options for both full-time and part-time engagement. The compensation package is competitive, with excellent benefits and bonus opportunities.
We are seeking a dedicated Regulatory Manager who can effectively manage compliance processes and documentation. The ability to start within a reasonable timeframe is preferred.