RA Specialist

RA specialist position for a growing Aesthetic Medical Device Company.

The role consists of ;

Prepare and maintain TDs and registration applications

Familiar with EU / US / AMAR regulations

Regulatory support for R&D projects and engineering changes

Participation in internal & external audits

Providing a regulatory response to all parts of the company and distributors abroad Requirements:

Previous experience in a similar position at a medical device company

 Requirements:

Bachelor's degree inscienceengineeringg

High English proficiency

Familiar with international standards of medicaldevicese such as ISO13485, ISO 14971,and IEC 60601 standards Acquaintance with QA processes of medicaldevicese - advantage

Knowledge in risk management, V&V, and product development - advantage

The position is open for both women and men