Regulatory Affairs Assistant

vor 4 Wochen

Hamburg, Hamburg, Deutschland Olympus Vollzeit

About the Role

Olympus is seeking a highly motivated and detail-oriented Working Student to support our Regulatory Affairs team. As a key member of our team, you will assist in the preparation, review, and organization of regulatory documents required for submissions, including technical files, product registration dossiers, and labeling.

Key Responsibilities

  • Conduct research on regulatory requirements and standards for medical devices in different markets, summarizing and reporting findings to the regulatory team.
  • Support the preparation of regulatory submissions, including compiling data, formatting documents, and ensuring accuracy and completeness.
  • Maintain regulatory records, SOPs, and files in accordance with internal quality management systems.
  • Assist in preparing for audits and inspections, working with other departments to gather necessary information.
  • Perform general administrative tasks related to regulatory affairs, such as data entry, document filing, and scheduling meetings.

Requirements

  • Currently enrolled in a Bachelor's or Master's degree program in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
  • Strong interest in the medical device industry and regulatory affairs.
  • Basic understanding of medical device regulations (e.g., EU MDR, FDA) is a plus.
  • Previous experience or internship in a regulatory or quality assurance environment is also a plus.
  • Excellent organizational skills, attention to detail, and analytical and research skills.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and strong communication skills.

What We Offer

  • 17 EUR per hour
  • Proportionate vacation entitlement
  • Interesting and diverse tasks in an international working environment
  • Excellent mentoring structure with regular feedback
  • Up to 60% remote work possible

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