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Regulatory Affairs Associate (m/f), Croatia (16000LKQ)

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.

Qualifications

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


Primary Location: EMEA-Croatia-Zagreb
Job: Reg Affairs
Schedule: Full-Time
Shift: Day Job
Employee Status: Temporary
Job Type: Temporary Work / Fixed Term
Job Level: Associate / Support Staff
Job Posting: Mar 22, 2017



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