1 месяц назад
Senior Clinical Development Lead / Senior Medical Safety Physician (m/f/d) (Diagnostics)
3 843€
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Development Lead / Senior Medical Safety Physician (Diagnostics): Leading medical safety assessments across the full lifecycle of Roche diagnostic products with an accent on clinical risk analysis, regulatory communication, and postmarket safety. Focus on evaluating product complaints, preparing Health Hazard Evaluations and medical safety opinions, leading Safety Board medical assessments, and optimizing Medical Safety processes.
Location: Vienna, Austria; work is based at the Vienna office
Salary: Gross EUR 3,843 per month minimum, with a higher offer possible based on experience.
Company
GmbH, acquired by Roche, develops healthcare products and solutions across diagnostics, diabetes care, and personalized healthcare.
What you will do
- Lead medical safety activities across the full product lifecycle, from premarket risk evaluation through postmarket complaint resolution.
- Prepare Health Hazard Evaluations, Medical Risk and Safety Assessments, Risk Enablers, and criteria for potential reportable or safety issues.
- Evaluate product complaints and provide clinical guidance for postmarket issues across the Diagnostics portfolio.
- Process inquiries from international regulatory authorities concerning adverse-event reporting and product recalls.
- Represent Medical Safety in Safety Board meetings and provide medical assessments supporting board decisions.
- Deliver internal training and maintain procedural documents, guidelines, and SOPs/GSPs.
Requirements
- Degree in Human Medicine or equivalent, with hands-on clinical experience.
- Expertise in applied laboratory medicine and diagnostic methodologies is highly advantageous.
- Familiarity with EU IVDR (2017/746), US IVD regulations, and preferably medical devices and medical device software, including EU MDR (2017/745).
- Solid understanding of EN ISO 14971 and TR 24971 risk management standards.
- Strong collaboration, negotiation, analytical, adaptability, and decision-making skills.
- Fluent written and spoken English required.
Culture & Benefits
- Inclusive and equal working environment focused on patient benefit.
- Family-friendly career paths and flexibility of a modern workplace.
- Learning, knowledge sharing, and open feedback culture.
- Opportunities for professional and personal development.
- Focus on sustainability, healthy lifestyles, and improving healthcare outcomes.
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