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Regulatory Affairs Coordinator
vor 1 Monat
About the Role
We are seeking a highly motivated and detail-oriented Working Student to join our Regulatory Affairs team at Olympus. 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, summarize and report findings to the regulatory team.
- Support the preparation of regulatory submissions, including compiling data, formatting documents, and ensuring accuracy and completeness.
- Participate in maintaining regulatory records SOPs, and files in accordance with internal quality management systems (e.g., ISO).
- Assist in preparing for audits and inspections.
- Collaborate with other departments, including Quality Assurance, and Marketing, to gather necessary information for regulatory submissions and compliance activities.
- 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.
- Familiarity with technical documentation and regulatory submissions.
- Excellent organizational skills and attention to detail.
- Good analytical and research skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Strong communication skills, both written and verbal.
- Ability to work independently as well as part of a team.
- Proactive and eager to learn new 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 is possible.
We look forward to receiving your complete application, including a cover letter, CV, and references. Please apply via our website by clicking on "Apply now". Applications via mail cannot be taken into consideration.
