At Rieka Talent, we are currently looking for a Clinical Research Associate (CRA) to join an innovative and international company operating within the medical device industry.
This position offers the opportunity to play a key role in clinical investigations, evidence generation, and regulatory documentation within a highly regulated and fast-growing environment.
Position Objective
The CRA will provide clinical and scientific expertise across clinical studies within a medical device environment.
This role will be responsible for the clinical investigation lifecycle, including CRO coordination, clinical site identification, site feasibility, investigator engagement, clinical follow-up, and contribution to clinical documentation.
The position is critical in ensuring quality, consistency, and regulatory readiness of clinical evidence, supporting informed decision-making and compliance throughout the medical device lifecycle.
Key Responsibilities
Clinical Studies
- Design, plan, coordinate, and oversee clinical investigations for medical devices in compliance with EU MDR (2017/745), ISO 14155, and applicable regulations
- Identify and coordinate clinical investigation sites and investigators
- Conduct feasibility assessments and maintain site follow-up activities
- Act as the main point of contact for CROs, investigators, and clinical sites
- Draft clinical study protocols and essential clinical documentation
- Coordinate collection, review, and consolidation of clinical data ensuring quality and traceability
Clinical Documentation
Preparation and maintenance of clinical sections of Technical Documentation, including:
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Clinical Development Plan (CDP)
What the Company Offers
- Hybrid working model
- International and collaborative environment
- Opportunity to join a growing and innovative company
- Exposure to global clinical projects within the medical device sector
- High visibility and direct interaction with global teams
- Salary: approximately €60,000 (B/a band, depending on experience and profile)
