Regulatory Affairs and Compliance Specialist

What we offer

• Structured training and guidance from experienced Compliance and Quality Assurance professionals.

• The opportunity to develop practical expertise in Regulatory Affairs, Quality Assurance and compliance.

• Exposure to a diverse portfolio of clinical laboratory and clinical research services.

• Involvement in the development of procedures, compliance tools and Quality Management System improvements.

• A professional environment that encourages continuous learning and gradual development of autonomy.

About the Role

• Medicover Integrated Clinical Services is looking for a Regulatory Affairs and Compliance Specialist to join the Compliance and Quality Assurance team.

• The role will support the assessment and implementation of regulatory requirements applicable to clinical laboratory and clinical research services. Working under the guidance of the Director of Compliance and Quality Assurance, the Specialist will contribute to regulatory research, development of procedures and compliance documentation, contract review and selected Quality Assurance activities.

Our expectations

• University degree in life sciences, pharmacy, biology, biochemistry, biotechnology, medical laboratory sciences, biomedical sciences, quality management or a related field.

• Previous experience in Regulatory Affairs, Quality Assurance, compliance or another regulated life-sciences environment.

• General understanding of regulatory and Quality Management System principles.

• Experience in preparing or reviewing procedures, assessments or controlled documentation.

Good analytical and organisational skills, with attention to detail.

• Good written and spoken English.

Ability to translate requirements into clear and practical documentation.

• Willingness to learn and progressively develop expertise across different regulatory areas.

• Ability to recognise when a matter requires clarification or escalation.

• The Following Would Be an Advantage

• Familiarity with IVDR, MDR, ISO 13485 or ISO 15189.

• Experience in clinical laboratory, medical device, pharmaceutical, biotechnology or clinical research activities.

• Familiarity with in-house IVDs, Laboratory Developed Tests or Research Use Only products.

• Experience with risk assessments, CAPA, change control, audits, supplier qualification or Quality Agreements.

Support implementation of regulatory requirements within the MICS Quality Management System.

• Support the review of regulatory, quality and compliance provisions in contracts, Quality Agreements and Statements of Work.

Help identify applicable authorisations, certifications, notifications, validations and documentation requirements.

• Draft and update SOPs, Instructions, forms, checklists and other compliance documentation.

Identify contractual requirements that may be unclear, not applicable, unsupported by current capabilities or inconsistent with applicable requirements.

• Support regulatory and compliance risk assessments, impact assessments and gap analyses.

• Contribute to regulatory aspects of assessments involving health, genetic or other sensitive data, in cooperation with the Privacy function.

• Support gap assessments and implementation activities related to ISO 13485 and other relevant standards or certifications.

• Monitor relevant regulatory developments and assist in assessing their impact on MICS activities.

• Provide support for selected Quality Assurance activities, including QMS documentation, client questionnaires, audits, nonconformities, corrections and corrective actions management, change assessments and supplier qualification.

• Maintain relevant regulatory records, trackers and supporting evidence.