Medical Device Product Expert
vor 2 Wochen
About TÜV Rheinland Group
TÜV Rheinland Group is a global leader in testing, inspection, certification, training, and knowledge services. With a strong focus on innovation and quality, we empower businesses and individuals to make safer, more sustainable decisions.
Opportunity: Medical Device Product Expert
Are you passionate about innovative solutions in the medical device industry? Do you thrive in a collaborative environment with experts who share your dedication to excellence?
We are seeking a highly motivated and knowledgeable individual to join our team as a Medical Device Product Expert. In this role, you will contribute to the evaluation and certification of active medical devices, ensuring they meet the highest safety and performance standards.
Responsibilities:
- Conduct thorough audits and assessments of active medical devices according to relevant regulations and standards.
- Evaluate technical documentation, risk management files, and manufacturing processes.
- Collaborate with manufacturers to address identified issues and ensure compliance.
- Stay abreast of the latest industry trends and regulatory developments in the field of active medical devices.
Qualifications:
- Bachelor's degree in a relevant engineering or scientific discipline.
- Proven experience in auditing and evaluating active medical devices.
- Strong understanding of applicable regulations, standards, and guidelines (e.g., ISO 13485, IEC 60601).
- Excellent communication, interpersonal, and problem-solving skills.
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