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We are looking for a Manager, Post Market Surveillance, based in our Global HQ in Baar, Switzerland, to lead and maintain a global PMS system, ensuring compliance with international regulations and driving continuous improvement in product safety and performance.
Key Responsibilities:
- Lead a cross-functional PMS team and ensure effective collaboration across departments.
- Develop and execute PMS plans, ensuring compliance with EU MDR 2017/745, FDA, ISO 13485, and other global regulations.
- Manage PMS data collection, documentation, and reporting (PMSR, PSUR, ASR).
- Write and submit PSURs, ensuring adherence to regulatory requirements.
- Integrate PMS outputs into risk management and company processes.
- Monitor PMS performance, identifying KPIs, risks, and improvement opportunities.
- Support audits and regulatory requests from competent authorities.
Ideal Candidate Profile:
- 5+ years' experience in the life sciences industry, with at least 2 years in PMS or regulatory compliance.
- Strong knowledge of global PMS regulations, PSUR writing, data collection, and PMS planning.
- Degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field preferred.
- Analytical thinking, attention to detail, strong communication, and organizational abilities.
- Fluent in English; additional languages are a plus.
Following our Novoflex policy, we would envision this person to have regular face-to-face interactions with colleagues, averaging three times a week in office presence.
We are looking forward to receive your application through our ApplicantPortal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.