Medical Affairs & Training Director
8 days ago
Sant Cugat del Vallès
About Us Based in Barcelona and Treviso, INDIBA Group stands at the forefront of global leadership in Aesthetics, Beauty, Rehabilitation, Sports, Intimate Health, Pharma, and Animal Health solutions, standing on a rich 40-year history of scientific innovation. Our cutting-edge 448 kHz frequency technology is the cornerstone of our world-renowned therapies, empowering individuals to enhance their lives and accelerate recovery from injuries across various sectors. With the integration of K-LASER, a global leader in medical lasers, we’ve propelled our commitment to advancing treatments, embracing new technologies, and expanding our global presence in medical research. Revitalizing lives is what we do and what our teams are working on to achieve daily. What are we looking for? We are looking for a senior leader to oversee the Medical Affairs & Training Department for INDIBA Group. This strategic role combines regulatory and clinical responsibilities with scientific communication and training leadership. The ideal candidate will bring deep medical expertise, strong stakeholder engagement capabilities, and the ability to align and transform clinical insights into business value while supporting company positioning. Which will be your responsabilities? • Lead the development, maintenance, and strategic use of clinical evidence to support product registration and ensure compliance with global medical device regulations., • Oversee the preparation of clinical documentation, including trial protocols, regulatory submissions, and reports to health authorities and notified bodies., • Supervise clinical trials and post-market surveillance, maintaining strong relationships with key opinion leaders (KOLs) and investigators to support research and product positioning., • Act as a key medical representative in audits, inspections, and quality reviews requiring scientific justification or expertise., • Provide scientific support and strategic guidance across internal departments including Commercial, Marketing, R&D, Regulatory and Quality., • Guide the development of scientific materials, publications, and congress contributions to reinforce K-LASER and INDIBA's position in the medical community., • Lead the Training team to ensure delivery of consistent, high-quality programs aligned with the latest clinical data, approved product claims, and corporate objectives., • Monitor emerging clinical trends and innovations to inform product development and positioning., • Ensure the effectiveness of the medical vigilance system in collaboration with relevant departments. What do you need to be a succesful candidate? • Minimum of 10 years’ experience in Pharmaceutical Laboratory, Medical Devices company or regulatory consultancy, in areas such as Medical / Scientific Department, Clinical Research, Medical Writing, Scientific marketing or equivalent., • Experience in writing clinical reports (expert reports, review reports, clinical, pharmacological, pharmacovigilance, phase III / IV studies, or similar) is essential., • Academic background: Degree in Health Sciences (Medicine, Pharmacy, Human Biology or Biomedical Science). Master's or post-graduate studies aimed at the Pharmaceutical, Cosmetic and/or Aesthetic and Rehabilitation Medicine Industry as well cinical trial monitoring will be valued., • Good command of Clinical research methodology., • Fluent Spanish & English language skills in both verbal and written communication. Fluency in another language will be a plus. What we offer? • Full-time and permanent contract., • Location: Sant Cugat del Vallés., • Hybrid work model, • Attractive remuneration package., • Fringe benefits., • Multinational and flexible environment. #J-18808-Ljbffr
Helena D.Active 8 months ago
