Not Available

Cyprus

Medicover Public Co Ltd.

Regulatory Affairs and Data Protection

Biologists - Physicists - Chemists

Quality Assurance & Testing

Ref.: 2025/07Who we are:Medicover is a specialized provider of diagnostic and healthcare services, focusing on markets mainly in Central and Eastern Europe and India. The company operates through two divisions – Diagnostic Services and Healthcare Services.Diagnostic Services – provides a broad range of laboratory testing in all major clinical pathology areas. The business is conducted through a network of more than 104 laboratories, 876 blood-drawing points (BDPs) and 27 clinics. Major markets are Germany, Ukraine, Romania and Poland.Medicover Genetics, which is a Business Unit within Diagnostic Services, has over two decades of expertise in genetic testing with:<ul><li>A range of services from send-out model to platform deployment and Technology Transfer</li><li>Expert teams with 150+ scientists and specialized physicians in multiple geographies</li><li>6,000+ genetic tests spanning several technologies</li><li>End-to-end clinical workflow with a sequencing core facility and tailor-made bioinformatics solutions and genetic counselling.</li></ul>Medicover’s purpose is to improve and sustain health and well-being. As a forward-looking healthcare company, we care about our employees, helping them stay safe, healthy, and productive.&nbsp;Do you want to make a difference, shape the future and to work for a growing, innovative diagnostic services company, with a purpose? Are you driven by reaching and exceeding commercial targets? Are you looking for a role where your talents and achievements are recognized and appreciated?&nbsp;If so, this role at Medicover is the right choice for you and if you are interested in applying, please send your CV (in English) to <a href="mailto:hr.cy@medicover.com">hr.cy@medicover.com</a>, with subject 2025/07 Quality &amp; Regulatory Affairs Specialist, the latest by September 4th, 2025. Note: Only shortlisted candidates will be contacted. We appreciate your understanding in this matter.&nbsp;&nbsp;Job Summary:&nbsp;Medicover Genetics is seeking to recruit a passionate and self-motivated Quality &amp; Regulatory Affairs Specialist, to join our dynamic group of experts. Successful candidates will work in the Quality &amp; Regulatory Department of ‎the company and will have the opportunity to work with cutting-edge technologies in our ‎state-of-the-art facility in Nicosia.&nbsp;This role will report to the Quality &amp; Regulatory Affairs Senior Manager.&nbsp;The Quality and Regulatory Affairs Specialist will also act as the company’s Data Protection Officer (DPO). This is a dynamic and detail-oriented role that offers both challenges and rewards — from meeting quality and regulatory deadlines to the satisfaction of achieving successful product registrations in global markets.&nbsp;You will play a key role in supporting the CE marking of our in-vitro diagnostic medical devices (IVDs), with a strong focus on compliance under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). You will also oversee the organization’s compliance with GDPR data protection regulation as well as supporting the Quality Management System for our manufacturing and clinical services products.&nbsp;Your Role:The ideal candidate will support our Quality and Regulatory Affairs function by performing conformity assessment activities and preparing the quality and regulatory documentation required for product approvals and product certifications and accreditations. You will work closely with cross-functional teams and assist with ongoing efforts to maintain and enhance compliance with IVDR and ISO standards.&nbsp;Key Responsibilities:<ul><li>Ensure that the company’s products comply with applicable regulatory requirements in the regions where they are marketed</li><li>Keep up to date with evolving national and international medical device regulations, including IVDR, and relevant standards</li><li>Compile and maintain regulatory documentation, including technical files and dossiers for CE marking in line with IVDR (EU 2017/746)</li><li>Liaise with regulatory competent authorities and Notified Bodies as part of submission processes</li><li>Provide input and guidance to scientific and technical teams regarding regulatory strategy and documentation</li><li>Prepare for and participate in regulatory audits and inspections, as well as external audits</li><li>Monitor and interpret new or updated regulations and ensure timely integration into internal policies and procedures</li><li>Review and contribute to scientific data, reports, labelling, recalls, validation and verification activities to ensure compliance with applicable regulatory and quality standards</li><li>Advise on topics such as regulatory requirements for product development, labelling, and clinical study compliance</li><li>Monitor compliance with the General Data Protection Regulation (GDPR) and other applicable data protection laws</li><li>Serve as the main point of contact for data subjects and regulatory authorities on privacy matters</li><li>Maintain and update company data protection policies and procedures</li><li>Provide guidance and training to staff on data protection best practices</li><li>Oversee data protection impact assessments and ensure appropriate safeguards are in place</li><li>Collaborate with other department teams to ensure records of processing activities are maintained</li><li>Ensure the continued compliance with ISO 13485, ISO 9001, ISO 15189, ISO 27001 and the College of American Pathologist accreditation</li><li>Monitor and maintain the company’s existing Quality Management System</li></ul>&nbsp;Your Profile:<ul><li>A degree in a relevant scientific, biomedical, or engineering field</li><li>2 – 3 years of experience in Regulatory Affairs, preferably within the medical device or IVD industry</li><li>Demonstrated working knowledge of EU IVDR and experience supporting CE marking submissions</li><li>Proven understanding of GDPR and practical experience in data protection compliance</li><li>Demonstrated knowledge of ISO 27001, ISO 13485 and ISO 15189</li><li>Strong attention to detail and excellent document review skills</li><li>Good organizational and time management skills, with the ability to meet tight deadlines</li><li>Excellent written and verbal communication skills, both in Greek and English</li><li>Ability to interpret technical and legal documentation</li><li>Experience interacting with Notified Bodies is desirable</li><li>Familiarity with ISO 14971 is an asset</li></ul>What we offer:<ul><li>Competitive remuneration package based on qualifications &amp; experience, including 13th salary</li><li>One afternoon off per week</li><li>Provident Fund</li><li>Increased vacation days according to years of employment</li><li>Interesting and dynamic job in a growing, entrepreneurial work environment within an international team</li><li>A friendly and respectful departmental and working atmosphere, as well as an open communication culture and team events</li><li>Career development and advancement opportunities, including training opportunities</li></ul>&nbsp;Medicover Genetics is an Equal Opportunities Employer. All applications are strictly confidential.

Quality & Regulatory Affairs Specialist

Quality & Regulatory Affairs Specialist

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