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We are seeking a highly skilled and motivated Clinical Affairs Specialist to join our Regulatory and Clinical Affairs team. The Clinical Affairs Specialist will be responsible for overseeing all clinical aspects related to our surgical and aesthetic laser devices, from pre-market clinical evaluation to post-market surveillance, including Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Vigilance activities. You will collaborate closely with cross-functional teams, including R&D, regulatory affairs, quality assurance, and marketing, to ensure that our products meet regulatory requirements, deliver clinical excellence, and maintain post-market safety and performance.
- Collaborate closely with the Clinical Affairs Coordinator to develop and implement clinical affairs strategies and plans for surgical and aesthetic laser devices in accordance with applicable regulatory standards and guidelines.
- Conduct literature reviews and stay updated on relevant scientific and clinical developments in the field of surgical and aesthetic lasers, specifically focusing on clinical investigation methodologies and evaluation techniques.
- Design and manage clinical studies, including protocol development, study monitoring, data collection, and analysis, following the MDCG guidelines and best practices for clinical investigations.
- Generate and collect study documentation such as consent forms, Case Report Forms, and Investigator Agreements.
- Contribute to the development of a laboratory infrastructure and related procedures to carry out histological analyses, aimed to evaluate the effects of the lasers on tissues.
- Develop and implement Post-Market Surveillance (PMS) strategies and activities, including the collection, analysis, and reporting of post-market clinical data and feedback, including adverse event reporting, complaint handling, and product performance monitoring.
- Coordinate and conduct Post-Market Clinical Follow-up (PMCF) studies to gather clinical evidence on the safety and performance of our surgical and aesthetic laser devices, adhering to the MDCG recommendations for PMCF studies.
- Interface with key stakeholders, including healthcare professionals, regulatory authorities, and clinical investigators, to establish effective relationships and obtain necessary clinical data and feedback.
- Assist in the preparation of regulatory submissions, including clinical evaluation reports, pre-market notifications applications (510(k)), and Post-Market Surveillance (PMS) reports.
- Contribute to the development of clinical claims, product labeling, and marketing collateral to ensure accurate and appropriate representation of clinical data.
- Ensure compliance with relevant regulations and standards, such as EU Medical Device Regulation (MDR), ISO 13485, FDA regulations (including 21 CFR 820).
- Bachelor’s degree in a relevant scientific field (e.g., biomedical engineering, biology, medical sciences).
- 2+ years in clinical affairs or clinical research within the medical device industry, with specific experience electromedical devices.
- Strong understanding of regulatory requirements and standards applicable to medical devices.
- Experience in designing and managing clinical studies, including protocol development, study monitoring, and data analysis.
- Knowledge of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) requirements and activities.
- Experience in conducting Vigilance activities, including adverse event reporting and complaint handling.
- Good written and verbal communication skills in English, including the ability to effectively communicate complex scientific and technical information.
- Attention to detail and strong organizational skills.
- Familiarity with statistical analysis methods and software used in clinical research is considered a plus.