Regulatory Affairs Specialist

Occlutech Tıbbi Ürünler San. Ve Tic. Ltd. Şti.

Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company manufactures, develops, sells and markets Class III medical devices for the transcatheter repair of structural heart defects, including a range of specialized devices for patients with atrial fibrillation or heart failure, in over 80 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden.

Location:       Global (Jena or Istanbul)

Reports to:     Global Head of Regulatory and Quality

Position Description:

Broad Function

Product registrations for regulatory approvals in Asia (excluding Japan), New Zealand, Middle-East, Mexico, Central and South America, Russia and South Africa.

Your work will focus on

• Submission, monitoring and routine updates to the product registrations in Asia, New Zealand, Middle-East, Mexico, Central and South America, Russia and South Africa.
• Maintain Country and Regional License renewals and annual registrations.
• Interpret existing and/or new regulatory requirements as they relate to products and procedures in the applicable countries.

We are looking for a candidate, who has

• Technical Scientific Degree (minimum Bachelors of Science)
• Experience in registrations of medical devices
• Knowledge of applicable international regulations and standards
• Broad general knowledge and experience with international requirements and directives applicable to medical devices
• Exceptional knowledge of English, any additional languages are a plus (including Chinese)
• Exceptional social and communication skills

If you are

·         A team player who likes challenges

·         A confident user of standard office software

·         Excellent in leadership, communication, organization and time management

Then we can offer you an interesting job in a team of people who like to work together and always focus on helping our customers to save and improve patient’s lives with innovative and highest quality products.