Regulatory Strategy Lead – Medical Devices (EU CE/MDR)

BD; Durham (NC); Sur place; USD 66 000 - 100 000; Plein temps

Résumé du poste

BD is seeking a Regulatory Affairs professional to advance regulatory strategies for Pharmacy Automation products in Germany. You will guide product development to ensure CE marking and compliance with the Machinery Regulation, review technical documentation, and support market access globally.

Requirements include a bachelor’s or master’s degree in medical engineering or related field, plus regulatory experience in medical devices and fluent German and English.

Qualifications

• Regulatory affairs experience in medical devices.
• Degree in medical engineering or related field.
• Proficiency in written and spoken German and English.

Responsabilités

• Develop and execute regulatory strategies for Pharmacy Automation products.
• Provide regulatory guidance throughout product development and lifecycle.
• Support CE marking and EU machinery regulation compliance.
• Oversee Technical Files, declarations, and documentation.
• Assess regulatory changes and determine required actions.
• Identify country-specific requirements and worldwide market access.

Connaissances

Regulatory affairs

Medical devices

German language

English language

Formation

Bachelor’s or Master’s degree in medical engineering/medical technology or related field

Description du poste

BD is seeking a Regulatory Affairs professional to advance regulatory strategies for Pharmacy Automation products in Germany. You will guide product development to ensure CE marking and compliance with the Machinery Regulation, review technical documentation, and support market access globally.

Requirements include a bachelor’s or master’s degree in medical engineering or related field, plus regulatory experience in medical devices and fluent German and English.