Working Student

Vor 6 Tagen

Hamburg, Deutschland Olympus Europa SE & Co. KG (OEKG) Vollzeit

**Responsibilities**:

- As Working Student (M/F/d) you assist in the preparation, review, and organization of regulatory documents required for submissions, including technical files, product registration dossiers, and labeling.
- You conduct research on regulatory requirements and standards for medical devices in different markets, Summarize and report findings to the regulatory team.
- Part of your Tasks is also supporting the preparation of regulatory submissions, including compiling data, formatting documents, and ensuring accuracy and completeness.
- You participate in maintaining regulatory records SOPs, and files in accordance with internal quality management systems (e.g., ISO 13485). You also assist in preparing for audits and inspections.
- You work with other departments, including Quality Assurance, and Marketing, to gather necessary information for regulatory submissions and compliance activities.Performing general administrative tasks related to regulatory affairs, such as data entry, document filing and apostille and scheduling meetings are part of your Duties

Your qualification
- You are currently enrolled in a Bachelor’s or Master’s degree program in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
- You have a strong interest in the medical device industry and regulatory affairs.
- A 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.
- You have familiarity with technical documentation and regulatory submissions.
- You have excellent organizational skills and attention to detail.
- Good analytical and research skills are part of your Qualifications.
- Your competencies include proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- You have strong communication skills, both written and verbal.
- You have the ability to work independently as well as part of a team.
- You are proactive and eager to learn new skills.

Your benefits
- 17 EUR per hour
- Proportionate vacation entitlement
- Interesting and diverse tasks in an international working environment
- Excellent mentoring structure with regular feedback

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