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.

Getinge Group is in an exciting and intensive period of change and you will be a key player as we are building a new Quality Regulatory Compliance (QRC) organization. We are strengthening our Business Category Unit Acute Care Therapies (ACT), also known under the brand Maquet, with two Regulatory Affairs Managers.

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!

The position

As a Regulatory Affairs Manager you will be member of the Regulatory Affairs and QA expert team for the product areas Ventilation, Anesthesia, Accessories and Monitoring towards internal and external customers.

Among your main responsibilities and tasks will be to:

•Establish documentation for CE-marking, i.e. Technical File, Essential Requirements Checklist and Declaration of Conformity

•Develop and submit applications to 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 sale and service units

•Support the R&D and market introduction projects

•Support Product Maintenance

•Continuous improve the processes

The position is located at our site in Solna and you will be reporting to the Director of Product Compliance. International travel is expected on an occasional level.

The ideal candidate

As ideal for the position you have at least five years’ experience within QA/RA from the medical device industry. Experience from regulations and standards, such as QSR, MDD, ISO13485 and IEC60601, is beneficial. 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.

As a person you are 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.

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 25th of August if you are interested in the position. You are also welcome to contact Karl-Yngve Keck at +46-70-782 72 65 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 dep

Timmar per vecka: Heltid Tills vidare

Arbetsgivare Namn: Getinge Group AB

Arbetsgivare adress: P.O Box 8861 40272 Göteborg

Form av kontakt:
titel : telefon 1: () telefon 2: () mobil: e-post:

Jobb kort beskrivning:
Business services and administration managers not elsewhere classified

Land: Sweden

Område: Stockholms län

Avtalstid: Permanent

Typ av kontrakt: Full time

Källa till jobberbjudande: Public Employment Service of Sweden(AMS)

Hur man ansöker: Other - see free text