Principal Regulatory Specialist

The Principal Regulatory Specialist is required for a scaling bio sensor company working on medical devices for ECG monitoring.

The role will be to assess governing frameworks, regulatory requirements, and legislation throughout preclinical, clinical, and manufacturing processes.

The Principal Regulatory Specialist will be vital in identifying and anticipating regulatory obstacles throughout the development process and aid the team in circumventing emerging issues. They will determine requirements and documentation necessary for submission, approval, and compliance.

The key skills of the Principal Regulatory Specialist will include:

• Strategic leadership of regulatory projects and framework implementation
• Experience with ongoing review and evaluation of regulatory requirements
• Project Management experience
• Submission, registration, obtaining approval, documentation, compliance.
• Demonstratable knowledge in regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally.
• Submission, registration, obtaining approval, documentation, compliance.

If you have experience in the above, please make this clear in your CV.

For more information or to apply for the Principal Regulatory Specialist vacancy, please contact Chris Moffatt at IC Resources.