Regulatory Affairs Associate, Croatia - Medtronic - Zagreb

Job description

REGULATORY AFFAIRS ASSOCIATE, based in Zagreb, Croatia

(Adriatic West countries - Croatia, Slovenia, Bosnia and Herzegovina, Albania, Kosovo)

Temporary role (1 year).

Main responsibilities:
· Obtains timely regulatory approvals to meet business objectives
· Prepares and coordinates regulatory/registration submissions.
· Ensures that submissions meet relevant external and internal requirements.
· Ensures required documentation, questions and answers from authorities and approvals are filed in the appropriate systems.
· When/where applicable supports distributors to obtain the necessary regulatory approvals.
· Coordinates the execution of Field Corrective Actions.
· Provides support for vigilance reporting to the regulatory authorities.
· Coordinates translation of product labeling (IFU and Label) if applicable
· Maintains internal databases for regulatory compliance
· Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization.
· Provides support to tender offers in case of necessary regulatory documentation.

Desired profile

Key requirements:

· University degree (preferred: medicinal and natural sciences)
· Proven track record of relevant regulatory environment (min. 1 year of experience)
· Quality Assurance issues knowledge
· Strong attention to detail and quality in all reporting materials
· Compliance oriented
· Customer and solution focused
· Ability to work independently, self-starter
· Ability to communicate effectively to all levels of organization and customers (including regulators)
· Speak the local language
· Proficient in English, both written and spoken
· Comfortable experience with Database entry and management
· General knowledge of “good documentation practise”
· Computer skills