Regulatory Affairs Project Specialist
|Oblast:||Administratíva, office management,|
|Vydané:||08. 07. 2019|
Regulatory Affairs Project Specialist will assure support for CEE region, Medical Devices branch.
The main focus of the RA Project Specialist will be on Transformation projects and all regulatory activities associated with them. To ensure compliance of regulatory procedures for the Czech Republic, Slovakia and Hungary.
• Executes all regulatory activities on country level necessary to complete transformation projects.
• Participates on all projects related to portfolio transformation, supports the project manager and project team.
• Ensures regulatory compliance of consolidated medical devices with local regulations – responsibility for coordination and preparation of regulatory product notifications and registrations within the projects in given timelines.
• Responsible for various approvals in the Systems linked to job duties.
• Provides Regulatory support for business continuity and development.
• Responsible for copy review assessment and approval of our client´s MDs materials.
• Provides routine communication and updates to site and organizational management regarding projects.
• Ensure compliance of regulatory documents and procedures.
• Responds to product information requests.
• Provides Regulatory Affairs support during internal and external audits.
• Maintains regulatory tracking databases, including data entry, updates, and retrieval.
• Ensures readiness of local Regulatory Affairs department.
• Performs other work-related duties as assigned by manager.
• Regulatory Affairs experience at minimum 2 years.
• At minimum Bachelor´s degree or equivalent – medical, technical, legal education advantage.
• Excellent Czech/Slovak, Hungarian and English communication skills.
• Advanced knowledge of MS Office and data processing applications.
• Excellent interpersonal skills.
• Sense of importance and mission of the role, project experience advantage.
• Advanced organizational skills and attention to details.
• Ability to understand cross-enterprise data flow and systems.
• Strong analytical and organizational skills.
• Precise planning and execution to achieve accurate and timely results.
In accordance with the General Data Protection Regulation 2016/679 (hereinafter “GDPR”), I declare that have read and understood the content of the Privacy Notice, which was provided to me for my perusal and which is available at https://www.manpower.sk/manpower/sk/ochrana-osobnych-udajov/. I hereby acknowledge the following:
(i) my personal data will be processed by company ManpowerGroup Slovensko s.r.o., having its registered office at Lazaretská 8, 811 08 Bratislava, Slovak Republic, ID No.: 35958898, registered in the Business Register kept by District Court Bratislava I, Section: Sro, Insert No. 37879/B (hereinafter the “Controller”) in full compliance with all legal regulations, in the manner and scope delineated in the Privacy Notice; and
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