EXPERIENCE:

·        Min 3-5 years of experience 

·        Good  English communication skills

Position Overview - Basic Functions & Responsibility                                                                                                                                 

Under the direction of the Regulatory Manager, the incumbent:

• Manages artworks and labeling activities for products in order to support submissions and get products to market quickly.

•  Local owner of the company artwork management system

• Manages the registration of the medical devices to the local agency system (product tracking system) and keep agency’s medical device database up to date

• Coordinates internal checks with all the stakeholders involved and proactively work with artwork centers, in order to support submission and product launches in due time.

• Coordinates the approval process and the follow-up of the printing process to ensure proper implementation of artworks changes and avoid stock out situation.

• Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.

• Plans, tracks and gives (pro-)active follow up to all regulatory actions related to artworks and ensures full compliance with relevant legislation and with internal procedures.

• Ensures handling of customer complaints on CDT (Counterfeiting – Diversion – Tampering) as designated point of contact.