Quality Assurance Coordinator
vor 1 Woche
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at medi GmbH & Co. KG. As a key member of our Quality Management team, you will be responsible for ensuring compliance with global regulatory requirements for medical devices.
Key Responsibilities:
- Support the development and implementation of global regulatory strategies for medical devices.
- Conduct research and analysis of national and international regulations, standards, and guidelines.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Develop and maintain regulatory documentation, including quality management systems and technical files.
- Participate in audits and inspections by regulatory authorities and certification bodies.
Requirements:
- Bachelor's degree in a relevant field, such as law, business, or engineering.
- Proven experience in regulatory affairs, quality management, or a related field.
- Strong knowledge of medical device regulations, including EU MDR and FDA regulations.
- Excellent communication and project management skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A comprehensive benefits package, including health insurance and retirement plan.
- A generous paid time off policy.
- The chance to work on innovative projects and contribute to the company's success.
About Us:
medi GmbH & Co. KG is a leading global manufacturer of medical devices. We are committed to developing innovative solutions that improve patient outcomes and quality of life. Our team is passionate about making a difference and is driven by a shared vision of excellence.
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