Medical Device Documentation Specialist - Bausch + Lomb｜Meet.jobs
薪資
35k - 51k EUR Annually
技能需求
工作機會描述
Introduction
Bausch + Lomb (www.bausch-lomb.de) is one of the world's best-known names in eye care. As part of Bausch Health with more than 21,000 employees worldwide, we work in the areas of Pharma, Vision Care (contact lenses) and Surgical (eye surgery) to improve not only the vision but also the lives of millions of people. We have a significant market share in Germany and have been able to create a high level of awareness with well-known brands in all three product areas. Constant innovation and a strong growth strategy enable us to offer our employees excellent development opportunities and create attractive, inspiring workplaces.
Your tasks
- Support EU-MDR maintenance activities as assigned in Quality department
- Support documentation requests related to Medical Devices
- Participate in the implementation of Usability Engineering Process for Medical Devices
- Preparation of SOPs (Standard Operating Procedures)
- Support Post Market Clinical Follow-up Studies (PMCF) for Medical Devices and participate in the implementation in PMCF activities for the legal manufacturer
- Support Medical Device Risk Management team
- Maintain product information on company´s website and ensure that the information reflects the current status of marketed products and represent this topic in audits and inspections
- Ability to work with databases and applicable standards
Your profile
- Experience in the pharmaceutical industry or in the field of medical devices
- Experience in inspections/ audits
- Project management skills
- Strong organizational skills, detail orientated, ability to adapt in a fast paced constantly changing environment
- Adequate theoretical and practical knowledge for the performance of medical device activities
- Knowledge of MD requirements/respective laws with focus on Medical Device Regulation
- Good communication skills as well as fluent English and German skills written and spoken
- MS-Office and Database experience
We offer
- Attractive salary package for the pharmaceutical/chemical industry with many extra benefits
- Vacation and Christmas bonuses as well as other special benefits under the collective agreement
- Payment of an employer allowance for the company pension plan
- Collectively agreed, employer-financed supplementary nursing care insurance
- At least 30 days vacation
- 37.5-hour working week with flexitime arrangements for employees covered by collective agreements
- Teams with outstanding spirit in which we learn from each other and you can develop your potential
- Insights into a modern, internationally operating company with a lot of personal responsibility
- Career and further development, training and education programs
- Health check-ups, gym allowance
- Varied catering in our canteen
- Free parking on the premises and a subsidy for the VBB company ticket
We look forward to receiving your application!