Regulatory Affairs Specialist to Getinge
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).
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 Specialist you will be a member of the regulatory affairs and product compliance expert team for the product areas Ventilation, Anesthesia and Monitoring towards internal and external customers. You will have the opportunity to be a part of the team thru the whole development process, from idea to complete product.
Among your main responsibilities and tasks will be to:
- Support the R&D throughout the product development process
e.g. issue Quality Management Plans, participate in Risk Management and perform document review
- Establish documentation for CE-marking, i.e. Technical File, Essential Requirements Checklist and Declaration of Conformity
- Participate in creating risk analysis
- Review documents
- Develop and submit applications world wide, e.g. US and Canada, for market clearance/approval
- Support the sales and service units outside Europe, U.S. and Canada when those are applying for new or updated regulatory approvals
- Support the sales and service units in market introduction projects
- Support Product Maintenance
- Contribute to a successful EU MDR transition
- 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
- Continuously improve our processes
The position is located at our site in Solna.
Is this you?
As ideal for the position you have at least five years of experience within QA/RA from the medical device industry. Experience from regulations and standards, such as QSR, MDD/MDR, ISO13485 and IEC60601, is expected. Excellent skills in 510(K) submissions is desireable. Further, you have a Master degree 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 attritbutes will be of great importance! As a person you are accurat, 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.
Search: regulatory affairs, regulatory affairs manager, RA engineer, product management, MedTech, Medical Devices, quality assurance, compliance work, medical technician, system engineer, medicintekniker, systemingenjör
Together we can make a difference
At Getinge we are dedicated and passionate about helping our customers to save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. A position at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day!”