My client, an established Medical Device company in Scotland are looking for an experienced Regulatory Affairs Professional to join them on a 6 or 12 month contractual basis. There is a possibility or part-remote/remote working depending on experience.
Senior Regulatory Affairs Associate | Key Requirements:
- Involvement in, and maintaining an appropriate and effective regulatory strategy to achieve compliance
- Produce and review the technical and regulatory documentation in accordance with ISO 13485 and regulatory requirements in line with continuous improvement programmes and/or changes required through standards.
- Investigate, remediate and successfully conclude all regulatory issues that are product related.
- Support the regulatory team in processing global product registrations and approvals for chosen markets
- Support Risk Management activities
- Understand and apply quality assurance procedures in line with ISO 13485:2016 quality management system standards, the Medical Devices Directive 93/42/EEC (as amended) and Medical Device Regulation MDR 2017/745.
- Ensure personal compliance with internal regulatory, quality and other procedures.
- Ensure the company is compliant to global regulatory requirements for quality systems and product registrations
- A minimum of 5 years’ experience working within the medical device industry
- A high level of competence with MDD regulations
- Experience with high risk medical devices
- Lead pre-market submissions
- Sound understanding of ISO13485