Regulatory Affairs Specialist
Updated: April 30, 2024 04:30 PM GMT
BioTalent
AachenRole: Regulatory Affairs Specialist
Location: Aachen
About Us: This company is a a leading innovator in Medical Device specifically within the area of cardiology specifically manufacturing class II Devices
Key Responsibilities:
• Ensure compliance with regulatory requirements.
• Prepare and submit regulatory technical documentation such as participation in the creation of validation and risk management documentation, UDI management, qualification and classification)
• Collaborate with cross-functional teams.
• Provide guidance and support to internal teams.
Qualifications:
• Strong understanding of FDA, EU, and international regulations
• Experience within the Medical Device space specifically working with class II or class III products
• German speaking is required
• Excellent communication and problem-solving skills.
To join a dynamic team shaping the future of healthcare regulation and compliance. Send your cv to leah.james@biotalent.com or click apply! More Detail
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