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Regulatory Affairs Associate (m/f), Croatia (16000LKQ)
REGULATORY AFFAIRS ASSOCIATE, based in Zagreb, Croatia
(Adriatic West countries - Croatia, Slovenia, Bosnia and Herzegovina, Albania, Kosovo)
Temporary role (1 year).
- 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.
- 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
Shift: Day Job
Employee Status: Temporary
Job Type: Temporary Work / Fixed Term
Job Level: Associate / Support Staff
Job Posting: Mar 22, 2017