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Regulatory Affairs Director
vor 2 Monaten
Job Title: Regulatory Affairs Manager
Company: Melio Life Science
About the Role:
We are seeking an experienced Regulatory Affairs Manager to join our team at Melio Life Science. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to drive business growth.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with MDR, ISO 13485, and 21 CFR part 820.
- Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product lifecycle.
- Provide regulatory expertise to support business growth and expansion into new markets.
- Stay up-to-date with changing regulatory requirements and ensure our products and processes remain compliant.
Requirements:
- Proven experience in Medical Devices, particularly in Quality and Regulatory departments.
- Strong knowledge and experience with MDR, ISO 13485, and 21 CFR part 820.
- Exceptional communication skills in both English and German.
What We Offer:
- A dynamic and growing company with opportunities for professional development.
- A collaborative and supportive work environment.
- A competitive salary and benefits package.
