Jobbeschreibung
At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Olympus Europa, headquartered in Hamburg, Germany, serves the EMEA (Europe, Middle East, Africa) region and employs 6,900 people in 31 countries. For more information, visit our website.
- 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 will research regulatory requirements and standards for medical devices in different markets, summarise and report findings to the regulatory team
- Supporting the preparation of regulatory submissions, including compiling data, formatting documents and ensuring accuracy and completeness, will also be part of your role
- You will assist in maintaining regulatory records SOPs and files in accordance with internal quality management systems (e.g., ISO 13485). You will also help prepare for audits and inspections
- You will liaise 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 will be part of your duties
- You are currently enrolled in a Bachelor's or Master's degree program in Life Sciences, Biomedical Engineering, Regulatory Affairs or a related field
- Previous experience or internship in a regulatory or quality assurance environment is advantageous
- A basic understanding of medical device regulations (e.g., EU MDR, FDA) is a plus
- You are familiar with technical documentation and regulatory submissions
- Your competencies include proficiency in MS Word, Excel and PowerPoint
- You have a strong interest in the medical device industry and regulatory affairs
- You have excellent organizational skills and attention to detail
- Good analytical and research skills are part of your qualifications
- You have strong communication skills, both written and verbal
- You have the ability to work both independently and as part of a team
- You are proactive and eager to learn new skills
- 17 Euro 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