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ATAT10 AZ Österreich GmbH

Regulatory Affairs and Medical Compliance Assistant(m/w/x)

Wien
from 46,768.8 / year
Full-timeWith Home OfficeExperienced
Apply now

Preparing regulatory documents like Fachinformation and Gebrauchsinformation for healthcare products. 3+ years industry experience and fluent English/German required. Bonus opportunities and flexible hybrid work.

Requirements

  • Matura/Abitur or equivalent education
  • International baccalaureate or equivalent education
  • At least 3 years' proven professional experience in industry or healthcare
  • Command in English and German (written and spoken)
  • Agile thinking with pragmatic approach
  • Efficient, meticulous, self-motivated working style
  • Project and process management experience
  • Strong organizational skills, oversight, manage complexity under timelines
  • Strong willingness to learn
  • Proficient MS Office
  • Ability to work with new technologies
  • Innovative and creative ideas within regulated setting
  • Strong interpersonal and team interaction skills

Tasks

  • Conduct activities in line with company values and compliance standards
  • Complete required training on the AZ Code of Conduct and policies
  • Report potential non-compliance issues
  • Maintain and develop Regulatory Sharepoints
  • Prepare Fachinformation, Gebrauchsinformation, and Fachkurzinformation
  • Document information on parallel imported products
  • Handle generic administrative tasks
  • Organize meetings, travel, and training
  • Support budget monitoring and control
  • Assist in product registration and maintenance
  • Ensure compliance with local and global codes and standards
  • Maintain and create RA SOPs and the Business Continuity Plan
  • Organize yearly BCP testing
  • Manage Regulatory Affairs digital and hardcopy archive
  • Ensure appropriate archiving according to retention guidelines
  • Support quality assurance and business compliance
  • Cooperate with Medical Affairs Assistant for essential tasks
  • Support Compliance Business Partner with Quarterly Compliance Monitoring

Work Experience

  • 3 years

Education

  • High school diploma

Languages

  • English – Business Fluent
  • German – Business Fluent

Tools & Technologies

  • MS Office

Benefits

Bonuses & Incentives

  • Bonus opportunities

Retirement Plans

  • Company pension scheme

Healthcare & Fitness

  • Supplementary insurance

Flexible Working

  • Flexible working hours
  • Hybrid work models

Learning & Development

  • Professional development support

Sustainability Focus

  • Environmentally conscious company
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AT10 AZ Österreich GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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