Regulatory Compliance Specialist
Vor 7 Tagen
We are looking for a Regulatory Compliance Specialist to join our team in Tolochenaz, Switzerland. As a key member of our quality team, you will be responsible for ensuring the compliance of our processes and products with relevant regulations and standards.
In this role, you will work closely with our manufacturing, engineering, and development teams to ensure that our products meet the highest quality standards. Your responsibilities will include:
- Developing and maintaining quality programs, systems, processes, and procedures that ensure compliance with policies and established internal and external standards and guidelines
- Leading local initiatives and contributing to global continuous improvement initiatives
- Providing oversight for change control, CAPA, documentation, audit, and/or training
- Presenting and defending process during notified bodies audits and regulatory authorities' inspections
You will have the opportunity to work in a dynamic environment with a highly motivated team of professionals. A strong understanding of ISO 13485, 21 CFR Part 820, and EU MDR is essential for this role.
The ideal candidate will have a minimum of 4 years of relevant experience in the medical device or pharmaceutical industry, with a focus on regulatory compliance. Strong communication and project management skills are also required. Fluency in French and English is necessary for this position.
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