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Regulatory Specialist
3 months ago
This innovative medical Device organization are seeking a Regulatory Affairs Specialist (RAS) to ensure that the company's products and processes adhere to all relevant regulations and standards.
The ideal candidate is a collaborative individual with excellent communication, problem-solving, and project/time management skills. They possess a background in regulatory compliance and value consistency. They will exhibit strong attention to detail and the ability to succeed in a dynamic environment while maintaining a focus on processes and procedures.
Some functions of the role are listed below:
- Ensure readiness for external audits by conducting and/or implementing internal audits as needed.
- Create, maintain, and monitor records and regulatory files as necessary.
- Help develop or improve compliance policies, procedures, and protocols essential for supporting operations.
- Ensure complete compliance with UDI labeling, database entries, codes, and user manuals.
The following qualifications would be preferred:
- Bachelor’s degree or equivalent in Regulatory Affairs or a related scientific field, plus over 5 years of experience in a relevant industry.
- 3+ years' experience within the medical device industry.
