Product Compliance Engineer

Every day, Getinge Group enables healthcare professionals to save lives. Based on first-hand experience and close partnerships, we provide innovative healthcare solutions to support before, during and after the patients’ hospital stay. Our company is built on a genuine compassion for people’s health and well-being. We approach our work with passion. In addition, our culture and behavior are guided by collaboration, openness, ownership and excellence – values we believe are the key to our success. Being part of Getinge Group means being an ambassador for these values and contributing to making a difference in peoples’ lives.

We are recruiting a Product Complaince Engineer for Getinge Sterilization AB, which is part of Getinge group, center of excellence for sterilization. We develop and manufacture units sold worldwide for the healthcare sector as well as highly customized units for the BioPharma and BioMedical sector. Getinge Group is in an exciting and intensive period of change and you will be a key player when it comes to ensuring compliance to regulations, global and local internal requirements and improvement initiatives. This position offers you a great opportunity to be part of an exciting journey, to contribute by making a difference. We are in a process to share common procedures globally and being integrated into a global Quality organization.

The position
The primary purpose of this role is to provide regulatory compliance strategies and ensuring successful product compliance for R&D and sustaining projects.

Your main responsibilities and tasks will be:

•Development of regulatory strategies supporting R&D product development and sustaining projects.
•Coordination of the preparation and approval of Technical Files
•Review and approval of project Quality Plans, V&V plans/protocols/reports, Design Reviews, and Risk Management activities.
•Review of integrity & maturity level of activities and technical documents contained in the Design History File
•Establishment of STED (Summary Technical Document) and the Essential Requirements Checklist
•Review and approval of marketing materials and labelling
•Be knowledgeable with the applicable standards, regulations, and directives that are required for ensuring product compliance.
•Interface with regulatory agencies and Notified Bodies as required with respect to technical file reviews.
•Act as the UDI Coordinator for the site and labeling and registration activities are being performed in compliance with the applicable regulations.

Support:
•Support the compilation of documentation for product regulatory registration and submissions for products as needed.
•Obtaining Free Sales Certificates and the Consular/ Notarization/Legalization of documentation.

The position is located in Getinge, Halmstad. The position reports directly to Manager, Product Compliance in the global Quality organization within Getinge Group.

The ideal candidate
As ideal for the position you have the following key characteristics:

•Bachelor’s Degree in any field of study, preferably Business or Engineering.
•Experienced in Quality Management / Reg. Affairs or related functions within a medical device or other regulated environment.
•Previous background and experience within other related functions, including product development, manufacturing, and operations.
•Good knowledge in applicable regulations and standards, e.g. FDA Quality Systems Regulations (21 CFR Part 820), ISO 9001, ISO 13485, ISO 14971, CMDCAS, MDD and product standards.
•Fluent spoken and written Swedish and English is necessary

As a person you have the:
•Ability to work well on cross-functional teams
•Strategic thinking but pragmatic and ability to make decisions
•Ability to work independently and can take quick decisions within its area of responsibility.

Application
Are you interested in becoming part of an international and market leading medical technology company whose products a make huge difference for patients, healthcare professionals and societies all around the world? Getinge offers a great opportunity to make a difference in a global and dynamic environment!

Welcome with your application no later than the 17th of Feburary if you are interested in the position. You are also welcome to contact Holger Ullrich at +49 173 2884099 if you have questions.
Background checks may be carried out.

Getinge Group is a leading global provider of innovative solutions for operating rooms, intensive-care units, hospital wards, sterilization departments, elderly care and for life science companies and institutions. With a genuine passion for life, we build quality and safety into every system.

Our unique value proposition mirrors the continuum of care, enhancing efficiency throughout the clinical pathway. Based on our first-hand experience and close partnerships, we are able to exceed expectations from customers – improving the every-day life for people, today and tomorrow.