Vigilance Manager Medical Devices Compliance

Vigilance Manager Medical Devices Compliance

Job Description:

We are committed to 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 over 100 years, we have pursued a goal of contributing to society by producing products designed to deliver optimal outcomes for customers around the world. Within our organization, we are the global competence center for development, production, and repair services for rigid endoscopy, bipolar high-frequency surgery, and reprocessing, employing about 3,600 individuals across 14 locations in Europe.

IT Languages:

• English
• German

The Vigilance Manager will be responsible for ensuring compliance with medical device regulations and managing safety data.:

Ensure compliance with reporting obligations for medical devices to Competent Authorities, adhering to various country-specific regulations, 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, 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

Spoken Languages:

• English, German

Skillset:

• Regulatory compliance expertise
• Quality management systems knowledge
• Analytical skills
• Decision-making abilities
• Excellent communication skills

Qualifications:

• 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
• ISO 13485 and FDA regulations
• Practical experience with vigilance reporting and complaint handling preferred
• Experience in monitoring and evaluating safety data for medical devices
• including reporting serious incidents to the relevant authorities 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 communicate and defend them effectively
• Business fluent in English; German is an advantage

Years of Experience:

5

Location:

Europe

Job Benefits:

• Additional medical services
• Company pension
• Sport activities/facilities
• Flexible working hours
• Fitness programs
• Incentives & events
• Parking space
• Employee discount
• Sabbatical
• Cafeteria
• Meal coupons
• Company medical officer
• Coaching
• Home office
• Extra day off

Working Conditions:

Full Time, Remote possible

Employment Type:

Permanent contract

Company Culture:

• Collaborative and innovative work environment that values employee growth and well-being.

Opportunities For Advancement:

• Potential for career growth within the organization and opportunities for professional development.

visa Sponsorship:

Available