Senior Clinical Evidence Leader

Teleflex

Athlone

On-site

EUR 110,000 - 140,000

Full time

10 days ago
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Job summary

Teleflex is seeking a Senior Clinical Manager – Clinical Evidence Generation to lead the Clinical Evidence Generation team across Anaesthesia, Urology, and Interventional Urology portfolios. You will ensure high-quality clinical evidence supporting regulatory compliance, product lifecycle management, and business objectives.

The role requires leadership in CERs, CEPs, PMCF, SSCPs, and RWE initiatives, with collaboration across Medical Affairs, Regulatory Affairs, Design Assurance, Biostatistics,

Qualifications

  • Bachelor's degree in Life Sciences, Biomedical Engineering, Clinical Research, Epidemiology, Public Health, or related field (Master's/PhD preferred).
  • 5–7 years' experience in Clinical Affairs, Clinical Evidence Generation, Regulatory Affairs, Medical Affairs or related functions in medical devices.
  • Experience leading Clinical Evaluation activities: CERs, CEPs, PMCF, SSCP, and clinical evidence generation.
  • Experience designing and supporting clinical investigations, PMCF studies, observational or real-world evidence studies.
  • Knowledge of Real World Data sources (EHRs, registries, healthcare databases) and their use in evidence generation.
  • Experience interacting with Notified Bodies, authorities (FDA or equivalents).
  • Demonstrated leadership, coaching, and cross-functional collaboration skills.
  • Fluency in English, both written and spoken.

Responsibilities

  • Lead the Clinical Evidence Generation team and ensure high-quality clinical evidence for MDR compliance and regulatory requirements.
  • Oversee CERs, CEPs, PMCF, SSCPs, literature surveillance and other lifecycle clinical evidence activities.
  • Provide scientific oversight of PMCF studies and RWE activities from design to data interpretation.
  • Support Integrated Evidence Plans and regulatory evidence requirements with Medical Affairs Strategy.
  • Collaborate with Regulatory, R&D, Quality, and external experts to align evidence generation with regulatory expectations.
  • Drive continuous improvement in evidence generation, analytics, and regulatory science.
  • Represent Teleflex in regulatory audits and interactions with authorities.
  • Coordinate multiple projects and report progress to management.

Skills

People leadership
Cross-functional collaboration
English fluency
Scientific writing
Regulatory affairs understanding

Education

Bachelor's degree in life sciences/related field
Master's degree or PhD preferred

Job description

Teleflex is seeking a Senior Clinical Manager – Clinical Evidence Generation to lead the Clinical Evidence Generation team across Anaesthesia, Urology, and Interventional Urology portfolios. You will ensure high-quality clinical evidence supporting regulatory compliance, product lifecycle management, and business objectives.

The role requires leadership in CERs, CEPs, PMCF, SSCPs, and RWE initiatives, with collaboration across Medical Affairs, Regulatory Affairs, Design Assurance, Biostatistics,

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