Job Description
medisana GmbH is one of the leading specialists in the home health care market.
As part of the OGAWA Group, one of the world's leading manufacturers of massage products, we are represented in more than 40 countries with various brands.
We are developing, promoting and distributing products in the categories of mobile health, health control, wellness, body care, therapy and healthy home for health- conscious consumers worldwide.
We are looking for an employee who wants to make the difference together with us. To strengthen our team in Quality Management and Regulatory Affairs department in Neuss, we are looking for you for exciting challenges as
MDR Specialist (all genders)
What you can look forward to:
- Committed team with short decision-making processes - we look forward to your input!
- Permanent employment contract - long-term cooperation is important to us
- Flexible working hours - We manage both: private and professional life
- 30 days annual leave - plenty of time to recharge your batteries
- Home office option - It doesn't always have to be the office
- Wide range of training opportunities - Every employee can use the GoodHabitz learning programme for free
- HRmony - The benefit that brings joy
- Bike leasing - We support a health-promoting and environmentally conscious alternative to the car
- Beautiful offices and modern technology - atmosphere combined with efficiency
- Structured and well-founded training - We take the time for you!
- A challenging and responsible job in a forward-looking industry - variety guaranteed
- Very good transport connections - by car, bus or train to work (parking spaces available)
- Implementation of the requirements of MDR and ISO 13485 in the internal and external processes of the quality management system of the company and its subsidiary, of post-market surveillance (PMS) as well as post-market clinical follow-up (PMCF) of medical devices and of the UDI requirements (Unique Device Identification) including the implementation of any European specifics.
- Support the Quality Management department in conducting internal and external audits and in the preparation and maintenance of the required audit documentation for the company and its subsidiary
- Communication with authorities or notified bodies on all topics relating to medical devices
- Creating the technical documentation of the products in accordance with the requirements from MDR and ISO 13485 in compliance with any other necessary legal and normative requirements
- Developing the department together with the team and optimize processes in collaboration with other technical managers for the transition from MDD to MDR
- Supporting the Quality Management department in processing customer complaints and create 8D reports on them
- Completed scientific training or studies in a scientific field (e.g. medical technology, biology, chemistry, pharmacy or comparable)
- 3-5 years of relevant professional experience in the field of medical device certification in a national and international context
- Experienced in:
- (Establishing) quality management system in compliance with relevant standards and requirements (MDR, ISO 13485, 21 CFR Part 820).
- Preparing/maintaining technical documentation for medical devices (Class IIa or higher) for submission to Notified Bodies and/or FDA.
- Conduct internal and supplier audits
- Market surveillance and CAPA management
- Product and process based risk management
- Characterized by an entrepreneurial approach and an analytical, structured work style and team spirit and combine assertiveness with the ability to deal with conflict and criticism
- Independent, goal- and result-oriented way of working and a hands-on mentality
- Moving and deciding fast in an always changing environment
- Confident in the use of common Microsoft Office programs
- Very good communication skills in German and English
Motivated and committed employees are a prerequisite for the success of our company. To this end, we offer you a varied job in a collegial working environment with a salary range. Innovative ideas are the cornerstone of our success as a leading provider of Connected Health products. You can expect interesting and challenging tasks in fields that influence our future, as well as a motivated and friendly team.
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