Are you interested in becoming part of an international and market leading medical technology company whose products make a huge difference for patients, healthcare professionals and societies all around the world? Apply to be a member of the Regulatory Affairs and Product Compliance team at Getinge (Maquet critical care).Om tjänstenThe Role
This position offers you a great opportunity to work cross-functional, locally and globally, with a wide variety of stakeholders inside the organization. It is an excellent chance for a talented and dedicated regulatory affairs professional to take part in improving world class med-tech products in a challenging regulatory environment with high ambitions within a global and fast-paced manufacturing organization!
As a Regulatory Affairs Manager you will be a member of the Regulatory affairs and Product compliance team taking ownership for the regulatory aspects of the product areas Perfusion, Ventilation and Anesthesia, towards internal and external stakeholders. The regulatory team strive for excellence in the regulatory process by taking a leading role in international standardization and development of Getinge global processes. You will have the opportunity to collaborate in an open climate, with a diversified team thru the whole development process, from idea to complete product.
Among your main responsibilities and tasks will be to:
- Establish documentation for regulatory approvals for example CE-marking, i.e. Technical File, Essential Requirements Checklist and Declaration of Conformity
- Submit and support applications world wide, e.g. US, China and Canada, for market clearance/approval
- Support the R&D throughout the product development process e.g. issue Quality Management Plans, participate in Risk Management and perform document review
- Support Product Care in communicating with authorities in relations to for example complaints and Field Actions.
- Take the lead or participate in cross-functional projects such as development of global Getinge procedures
- Within your area of expertise support the organization and e.g. participate in standardization and continuously improve our processes.
The position is located at our site in Solna.Är det här du?Is this you?
As ideal for the position, you have experience within QA/RA from the medical device industry. Experience from regulations and standards, such as QSR, MDD/MDR, ISO13485 and IEC60601, is expected. Further, you have a Master degree or corresponding education, in a relevant field together with fluent proficiency in Swedish as well as in English, which is our corporate language.
In this recruitment, your personal attributes will be of great importance! As a person you are accurate, action-orientated, driven and independent with a great amount of integrity. You have a coherent, challenging and process-oriented attitude and an excellent ability to communicate and collaborate with both internal and external stakeholders. An ability to work in a changing environment is also a key factor for this position.
Do you want to know more?
In this process Getinge is working with Level Recruitment. To apply, please click at the apply button. If you have any questions please contact recruitment consultant Emily Wadman at 08-120 50 428.
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