✨ The Role in One Sentence

COLDPLASMATECH is seeking a Regulatory Affairs Manager to support the creation and maintenance of medical product documentation and manage product registrations.

📋 What You'll Likely Do

• 40%: Support the creation and maintenance of medical product files / technical documentation according to FDA and MDR requirements.

• 30%: Manage product registrations in various countries and handle communication with authorities.

• 30%: Participate in market surveillance (PMS) and clinical follow-up (PMCF).

🧑‍💻 Profiles Doing This Job

• High Priority: Degree in Regulatory Affairs or a natural science/technical field.

• High Priority: Knowledge and experience in Regulatory Affairs and product development, ideally with a MedTech background in the USA.

📈 How This Role Will Look on Your CV

• Supported regulatory affairs for a MedTech company, ensuring compliance with international standards and regulations.