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Regulatory Compliance Officer
2 months ago
**About Bio Source Ltd (a Logik Source company)**
We are a MedTech company focused on the development of IoT medical wearable technology. Our company is committed to delivering innovative solutions that improve patient outcomes.
Job Summary
We are seeking a highly skilled Regulatory Compliance Manager to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our medical devices.
Key Responsibilities
- Conduct internal and regulatory audits to ensure compliance with ATEX, FDA, and CE Medical Devices regulations.
- Manage the technical file and ensure all documentation is up-to-date and compliant.
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product development lifecycle.
- Develop and implement processes to ensure ongoing compliance with regulatory requirements.
Requirements
- Proven experience in Medical Regulator Approvals within BioTech or MedTech.
- Experience with internal and regulatory audits, including ATEX, FDA, and CE Medical Devices.
- Strong management skills and ability to lead cross-functional teams.
- Excellent communication and interpersonal skills.
What We Offer
We offer a competitive salary of £50K FTE, with the option to work part-time. Our company also offers excellent benefits and bonus opportunities.
