Regulatory Affairs Intelligence Manager (m/f/d)

Regulatory Affairs Intelligence Manager (m/f/d)

Olympus Winter & Ibe GmbH (OWI)
Chief Quality Officer
Start from February 2025, full-time position, limited contract for 15 months due to parental leave.

Shape the Future of Global Regulatory Strategy with Olympus!
Are you ready to step forward in monitoring and responding to international regulatory changes? Join Olympus, a global leader in medical technology and life sciences, as a Regulatory Affairs Intelligence Manager. In this vital role, you will drive the identification and assessment of regulatory requirements, ensuring compliance and readiness across our global operations.

Your Responsibilities

1. Gather and maintain up-to-date knowledge of regulatory requirements relevant to Olympus’ products and processes worldwide.
2. Perform completeness checks to determine if impact assessments are needed for new or updated regulations and standards.
3. Collaborate with stakeholders to identify necessary changes to sustaining products and processes, ensuring alignment with evolving regulations.
4. Provide regulatory support for portfolio management in response to changes in regulations or standards.
5. Act as a resident member of the change board, contributing to regulatory decision-making processes.
6. Create and implement approval strategies tailored to specific regional requirements.
7. Serve as the primary point of contact for suppliers regarding regulatory matters.
8. Perform operational tasks within the Regulatory Affairs department to ensure compliance and efficiency.

Your Qualifications

1. A diploma, bachelor’s, or master’s degree in engineering or a related field, or equivalent qualifications.
2. Up to two years of professional experience in regulatory affairs or a related discipline.
3. Experience working on registration or development projects, with familiarity in managing initial phase projects.
4. Strong understanding of regulatory processes, controls, and frameworks.
5. Excellent proficiency in English, both written and verbal; additional language skills are a plus.
6. Strong communication skills to effectively act as an interface between different cultures and stakeholders.

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 in-house 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.