11 ago
|
RIEKA TALENT
|
España
11 ago
RIEKA TALENT
España
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 *********), ISO *****, 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 general 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:
What We Are Looking For
Education
University degree in a health-related or biomedical field such as:
Medicine
Pharmacy
Biomedical Sciences
Life Sciences
Nursing
or equivalent
Experience
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
Languages
Fluent English and Spanish (written and spoken)
Another European language is considered a plus
📌 Clinical Research Associate (Cra) (España)
🏢 RIEKA TALENT
📍 España