02 ago
|
RIEKA TALENT
|
España
02 ago
RIEKA TALENT
España
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.
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 general 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