Clinical Evaluation Specialist
vor 4 Wochen
At PAUL HARTMANN AG, we are dedicated to enhancing healthcare outcomes and supporting professionals in their mission to improve lives. We invite you to be part of our global team, where your contributions will help shape the future of healthcare.
Position Overview:
As a Clinical Evaluation Manager, you will play a pivotal role in overseeing the clinical evaluation processes and ensuring compliance with regulatory standards. This position offers a dynamic and challenging environment where you can develop your expertise and make a significant impact.
Key Responsibilities:
- Maintain and update clinical evaluation documentation, including post-market clinical follow-up and post-marketing surveillance.
- Facilitate cross-departmental communication with teams such as Marketing and Research & Development to ensure documentation accuracy.
- Coordinate with external service providers to support clinical evaluation documentation, PMCF, and PMS activities.
- Identify clinical evidence requirements in accordance with MDR and relevant MDCGs.
- Conduct literature searches and reviews in compliance with MDR/MEDDEV 2.7.1 rev. 4.
- Provide support for risk analysis and study planning for CE and PMCF studies.
Qualifications:
- A university degree in life sciences, natural sciences, or a related field.
- Professional experience in the medical device sector or a related regulatory environment.
- Knowledge of regulatory requirements, including MDR and relevant MDCGs.
- Experience in literature search and review, along with regulatory medical writing skills.
- Proficiency in database management and a strong command of MS Office.
- Fluency in written and spoken English.
Benefits:
- Flexible working arrangements, including adaptable hours and remote work options.
- Generous paid leave, including special leave for significant life events.
- Company pension plan with attractive employer contributions.
- Access to fitness and wellness programs, including skin cancer screenings and mental health resources.
- Job Bike Leasing and discounts on travel, fashion, and technology.
At PAUL HARTMANN AG, we are committed to fostering a culture of trust and openness. Join us in our mission to make a difference in healthcare.
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