Invacare Corporation, headquartered in Elyria, Ohio, is the global leader in the manufacture and distribution of innovative home and long-term care medical products that promote recovery and active lifestyles. Invacare employs approximately 5,000 associates and markets its products in 100 countries around the world. The Company is listed on the New York Stock Exchange under the symbol IVC.
Invacare's vision is to design, manufacture and deliver the best value in medical products that promote recovery and active lifestyles - making life's experiences possible.
Invacare seeks an enthusiastic and talented professional to join the position of a
QA RA R&D Manager EMEA based at our site Küschall AG in Witterswil (near Basel, Switzerland).
In this role, you enable Europe and Corporate (global) to understand the requirements from harmonized Standards, Medical Device Directive and Laws (e.g US FDA) regarding our products, documentation, services and support. You manage changes driven by legal and normative updates, to ensure that our products, services and documents are compliant to regulatory requirements globally. This is especially a focus in all external communication.
You follow all of our current new and sustaining Engineering projects and assure compliance to our European Quality Management System by consulting and visit to our regional Center of Excellence.
In detail, your key responsibilities in this role will be:
- Maintenance, training and support of European standards database, by administration of harmonized standards and management of updates
- Creation and maintenance of regulatory product group based requirements for product, documentation and service release
- Leading the organization on all requirements affecting market access (e.g. MDD, 510(k), RoHS) by support on a EMEA level
- Enabling engineering change process including updates of laws, medical requirements and standards
- Reviewing and checking normative requirements for documentation (user guides, sales leaflets, etc.)
- Coordinating requirements for European Test Plan (ETP) by reviewing regulatory issues, to close existing gaps, to enable robust design and consistent test requirements
- Supervising all new product development and sustaining engineering from a regulatory point of view.
Furthermore, you ensure the achievement of the targets and business development objectives. You coach and support the R&D EMEA organization to achieve their results. In addition, you implement appropriate management tools to minimize potential business risks.
You are part of the QA RA EMEA management team.
You hold a Master degree in Engineering (or equivalent). You have experience in MDD, ISO13485, ISO14791 and US FDA 820. Furthermore, it would be a plus if you have internal or external qualification as an auditor for Medical Device companies.
You have proven your ability to implement quality systems in a Medical Device development environment and can train and educate people on quality subjects. You are a self-driven person, who is experienced in leading people by example. You are used to work in a multinational environment and are used to work in a matrix organization. In addition, you are IT literate and fluent in English, any other language would be an asset. You are willing to travel up to 30 % of your time.
If you are interested in this position, please send your application to email@example.com. We are looking forward to receiving your application.
Frau Karen Bruttel
Sr. HR Generalist
061 487 70 17