Clinical Specialist

• Lead the preparation, review, and maintenance of clinical and technical documentation, including CERs, PMCF Plans and Reports, SSCPs, and related clinical documents
• Ensure clinical documentation complies with EU MDR, ISO 14155, GCP, MEDDEV guidance, and internal procedures
• Provide clinical and technical support for regulatory submissions, product registrations, certifications, and responses to regulatory authorities
• Support planning, execution, and oversight of clinical investigations, including study documentation and Ethics Committee submission packages
• Review clinical study documents, reports, literature evaluations, and clinical data analyses
• Monitor clinical data quality and study conduct, identify compliance issues, and support audit and oversight activities
• Serve as Clinical Affairs subject matter expert for Regulatory Affairs, R&D, Post-Market Surveillance, Design Quality Assurance, Medical Affairs, Commercial teams, and other stakeholders
• Support risk management activities with clinical input and alignment between clinical evidence and product safety requirements
• Mentor and provide technical guidance to junior Clinical Affairs team members
• Identify process improvements and enhance Clinical Affairs procedures, systems, and best practices
• Maintain current knowledge of regulations, clinical standards, scientific literature, and industry trends

Senior Clinical Affairs Specialist supporting medical-device evidence and regulatory compliance at Establishment Labs

Senior Clinical Affairs Specialist

Senior Clinical Affairs Specialist supporting clinical investigations and regulatory documentation for Establishment Labs’ medical-device and women’s-health products. Ensuring clinical evidence, compliance, and submissions meet international standards.

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Senior Clinical Affairs Specialist