Senior Clinical Affairs Specialist

About the role

Establishment Labs is seeking a Senior Clinical Affairs Specialist to provide advanced clinical and technical expertise for both marketed and new medical devices. You will lead the creation and maintenance of critical clinical documentation, ensure regulatory compliance, and support cross‑functional teams in delivering safe, effective women’s health solutions.

Key responsibilities

• Lead preparation, review, and upkeep of Clinical Evaluation Reports (CERs), Post‑Market Clinical Follow‑up (PMCF) plans and reports, Substantial Clinical Evidence (SCE) dossiers, and related documents.
• Ensure all 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 authority responses.
• Plan, execute, and oversee clinical investigations, including study documentation and Ethics Committee submissions.
• Review study reports, literature evaluations, and data analyses for scientific validity and consistency.
• Monitor data quality, identify compliance issues, and support audit and oversight activities.
• Act as the Clinical Affairs subject‑matter expert for Regulatory Affairs, R&D, Post‑Market Surveillance, Design QA, Medical Affairs, and Commercial teams.
• Support risk‑management activities by aligning clinical evidence with product safety requirements.
• Mentor junior Clinical Affairs team members and provide technical guidance.

Required profile

• Extensive experience in clinical affairs within the medical device industry.
• Proven project‑management background and ability to lead cross‑functional initiatives.
• Strong knowledge of EU MDR, ISO 14155, GCP, and MEDDEV regulations.
• Experience preparing regulatory submissions and supporting clinical investigations.
• Ability to mentor junior staff and communicate effectively with senior management.

Required skills

• Clinical Evaluation Report (CER) authoring
• Post‑Market Clinical Follow‑up (PMCF) planning and reporting
• Substantial Clinical Evidence (SCE) documentation
• EU MDR compliance
• ISO 14155 knowledge
• Good Clinical Practice (GCP) standards
• MEDDEV guidance application
• Regulatory submission support
• Clinical investigation design and oversight
• Data quality monitoring and audit support
• Risk‑management integration