Regulatory Affairs Manager Medical Devices (all gender)

Regulatory Affairs Manager Medical Devices (all gender)

Olympus Winter & Ibe GmbH (OWI) Chief Quality Officer. From 01.03.2025, Fixed-term contract for 20 months with the option for permanent employment.

As a Regulatory Affairs Manager, you will play a vital role in ensuring the compliance and market success of our medical devices. This role focuses on sustaining activities for our existing product portfolio, supporting lifecycle management, and maintaining compliance across global markets. You will also contribute to new product development and navigate complex regulatory landscapes.

Your Responsibilities

1. Assess the regulatory impact of design changes and updates to the existing product portfolio of medical devices.
2. Ensure ongoing compliance with regulatory requirements across the US, EU, Japan, and other key markets.
3. Provide regulatory expertise within cross-functional teams for new product development.
4. Prepare and submit 510(k) premarket notifications to the FDA.
5. Develop and execute registration strategies for global markets.

Your Qualifications

1. A university degree in a technical field or equivalent professional experience in regulatory affairs.
2. Several years of experience in regulatory affairs within the medical device industry.
3. Proven expertise in preparing FDA premarket submissions (510(k)) and evaluating US registration impacts during change management.
4. Strong knowledge of relevant standards, such as IEC 60601 and ISO 14971.
5. Excellent written and verbal communication skills in English; proficiency in German is a plus.

Your Benefits

1. 30 days of annual leave
2. Up to 60% mobile work possible + flexible work time model with overtime compensation
3. Holiday and Christmas bonuses
4. Corporate benefits discounts for employees
5. Comprehensive company pension scheme and capital-forming benefits
6. Company restaurant with live cooking and healthy food (subsidized)
7. Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
8. Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
9. Various subsidized company sports groups and access to the inhouse company gym

About Olympus

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.

For more information, visit www.olympus-europa.com and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA.

Further Information

Valuing diverse perspectives and lifestyles is one of our core values. We would therefore like to encourage all people to apply – regardless of gender, restrictions, nationality, ethnic and social origin, religion, world view, age as well as sexual orientation and identity.