DESCRIPTION
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.
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.
-
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
Preparation and maintenance of clinical sections of Technical Documentation, including:
-
Clinical Evaluation Plan (CEP)
-
Clinical Evaluation Report (CER)
-
Clinical Development Plan (CDP)
-
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)
REQUIREMENTS
-
University degree in a health-related or biomedical field such as:
-
Medicine
-
Pharmacy
-
Biomedical Sciences
-
Life Sciences
-
Nursing
-
or equivalent
-
Previous experience in clinical studies management, including:
-
Study planning and initiation
-
Study oversight and coordination
-
Clinical data review and reporting
-
Experience within Clinical Development, Clinical Research, Medical Affairs, Regulatory Affairs, Medical Writing, or similar scientific roles
-
Previous CRA experience and/or CRA qualification
-
Experience in medical devices, aesthetics, or dermatology will be highly valued
-
Fluent English and Spanish (written and spoken)
-
Another European language is considered a plus
