Vigilance Manager

Job Summary

Olympus is seeking a highly skilled Vigilance Manager to join our team. As a key member of our regulatory compliance team, you will be responsible for ensuring compliance with reporting obligations for medical devices to Competent Authorities, adhering to various country-specific regulations such as Regulation (EU) 2017/745 (Medical Device Regulation, MDR) and UK Medical Device Regulations.

Key Responsibilities

• Collect notifications regarding complaints on medical devices, make informed reportability decisions, and coordinate appropriate actions to address these issues.
• Coordinate timely responses to information requests from Competent Authorities, ensuring all inquiries are handled efficiently.
• Notify non-Olympus legal manufacturers about potential safety-relevant complaints received from the market for further assessment, and gather additional information upon request, if applicable.
• Develop and implement process improvements in alignment with new internal and external requirements, ensuring continuous compliance and efficiency.
• Clearly explain and justify reportability decisions during audit situations, demonstrating thorough understanding and adherence to regulatory requirements.
• Provide comprehensive reports of ongoing activities to management upon request, ensuring transparency and informed decision-making.
• Participate in other ad-hoc duties and projects as required, contributing to the overall success of the organization.

Requirements

• University degree in engineering, medical field or a comparable professional technical qualification gained through relevant practical experience.
• Solid understanding of regulatory requirements and quality management systems, including the EU Medical Device Regulation (MDR), ISO 13485, and FDA regulations (21 CFR Parts 820, 803, 806).
• Practical experience with vigilance reporting and complaint handling is preferred.
• Experience in monitoring and evaluating safety data for medical devices, including reporting serious incidents to the relevant authorities is a plus.
• Strong analytical skills and keen attention to detail in assessing compliance and safety issues.
• Strong self-confidence, with the ability to make well-informed decisions and effectively communicate and defend those decisions.
• Therefore we require a business fluent level in English; German language is an advantage.

Benefits

• 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