Senior Regulatory Affairs Manager (m/f/d) EU-MDR Operations

Senior Regulatory Affairs Manager (m/f/d) EU-MDR Operations

Senior Regulatory Affairs Manager (m/f/d) EU-MDR Operations

Olympus Winter & Ibe GmbH (OWI) | Medical Systems | from 01.08.2024, unlimited contract, fulltime

• We are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.

• We are seeking an experienced and highly skilled Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.

Key Responsibilities:

• Lead and manage EU-MDR and global regulatory operations projects.
• Serve as an internal consultant and advisor to the Program Manager on all regulatory affairs matters.
• Support and manage EUDAMED related regulatory affairs activities
• Act as the SME for Summary Technical Documentation (STEDs) related to EU-MDR.
• Provide expertise and support for R&D and regulatory affairs-related requests and strategies.
• Support non-conformance (NC) and corrective and preventive actions (CAPA) with EU-MDR-related issues.
• Conduct training sessions on internal regulatory affairs and EU-MDR topics.
• Lead internal regulatory affairs project communication efforts.

Completed degree in Engineering, Medical, or Science, or a related field.

Minimum of 3 years of experience in Regulatory Affairs or Quality within the medical device industry, with specific management experience, ideally in a matrix organization.

Proven experience in global project management and stakeholder management with Notified Bodies.

Demonstrated experience in assembling and preparing regulatory submissions for medical devices.

Experience in cross-functional team environments.

Business-oriented mindset with a strong understanding of regulatory and quality management system (QMS) processes.

Experience in managing regulatory projects in a global work environment.

Exceptional written and verbal communication skills in English and conversational German are required.

30 days of annual leave

Up to 60% mobile work possible + flexible work time model with overtime compensation

Holiday and Christmas bonuses

Corporate benefits discounts for employees

Comprehensive company pension scheme and capital-forming benefits

Company restaurant with live cooking and healthy food (subsidized)

Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being

Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing

Various subsidized company sports groups and access to the inhouse company gym

About Olympus Medical Systems

The Medical Systems Division represents Olympus’ largest business domain and is the global market and technology leader for medical endoscopes. Olympus aims to continuously find better and more economical solutions to medical issues which improve the well-being of patients, enhance the working environment for doctors and nursing staff and help to develop the overall performance of health care providers.

About Olympus Medical Systems

The Medical Systems Division represents Olympus’ largest business domain and is the global market and technology leader for medical endoscopes. Olympus aims to continuously find better and more economical solutions to medical issues which improve the well-being of patients, enhance the working environment for doctors and nursing staff and help to develop the overall performance of health care providers.

More reasons to join our team

Further information:

What does this job offer you?
• Be at the forefront of regulatory affairs, driving strategic projects that impact global operations.
• Opportunity to represent Olympus at international RA congresses
• Access opportunities for continuous learning and career development in a dynamic and supportive environment.
• Work with a team of dedicated professionals committed to excellence and innovation in the medical device industry.
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.