Regulatory Affairs Specialist

BioTalent

Aachen

Role: 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

Apply Now

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