Working Student (m/f/d) Regulatory Affairs

Olympus Europa SE & Co. KG (OEKG) | Medical Systems | Working Students: max. 20 h per week for at least 6 months, starting October 2024Type of employment:

Working student

Function:

Quality / Audit / Corporate Governance

Location:

Hamburg

Reference Number:

80023732-29082024

Website:

Your 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
• Up to 60% remote work is possible
We look forward to receiving your complete application including cover letter, CV and references! Please apply via our website by clicking on "Apply now". Applications via mail cannot be taken into consideration.

About Olympus Medical Systems

Olympus is passionate about creating customer-driven solutions for the medical, life sciences, and industrial equipment industries. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping to detect, prevent, and treat disease; furthering scientific research; and ensuring public safety.
As a leading medical technology company, our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients and their safety. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications.
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