Senior Quality Compliance Specialist
hace 1 día
About the Role
We are seeking a Senior Quality Compliance Specialist to join our team at Edwards Lifesciences Gruppe. As a key member of our Quality team, you will play a critical role in shaping the development of groundbreaking technologies and ensuring that each stage of our innovation process meets the highest standards of integrity and safety.
About You
You will bring your passion for problem-solving and expertise in quality compliance to influence decision-making throughout the product lifecycle. Your work will involve optimizing product development to impact patients worldwide with pioneering technology. In this position, you will be responsible for fulfilling applicable medical device regulations in the region, including ISO 13485 and other relevant requirements for designated complaint handling units, as well as evaluating events for reportability to applicable regulatory bodies.
What We Offer
We offer a competitive salary package, estimated to be around €60,000 per annum, depending on experience. Our comprehensive benefits program includes opportunities for professional growth, a dynamic work environment, and a chance to work with a leading global structural heart innovation company. If you are passionate about improving patient outcomes and driven by a desire to make a meaningful contribution, we encourage you to apply.
Key Responsibilities
- Fulfilling applicable medical device regulations in the region, including ISO 13485 and other relevant requirements
- Evaluating events for reportability to applicable regulatory bodies
- Collaborating with cross-functional teams to ensure compliance with regulatory requirements
- Developing and implementing quality management systems and processes
Requirements
- Degree in a related field (e.g., life sciences, engineering, or business)
- Minimum 3 years of experience in quality compliance or a related field
- Strong knowledge of medical device regulations and industry standards
- Excellent problem-solving and communication skills
Why Join Us?
At Edwards Lifesciences Gruppe, we are driven by a passion to improve patient lives. Our innovative products and services help shape the future of healthcare, and we are committed to making a meaningful difference in the world. If you share our vision and values, we encourage you to explore this exciting opportunity and become part of our dynamic team.
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