Regulatory Affairs Manager
Randstad AB / Sjukhusteknikerjobb / Sundbyberg
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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 to take part in developing and improving world class med-tech products in a challenging regulatory environment 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 area of Anesthesia, Ventilation, Intra- Aortic Balloon Pump and Perfusion, 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 teams thru the whole product life cycle, from idea to release the product to market and through post market surveillance. This role leading cooperation between different sites within Getinge on a global level.
Responsibilities
Establish and maintain documentation for CE-marking according to MDR, i.e. Technical Documentation and Declaration of Conformity
Submit and support regulatory applications for China and US, 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 Post market surveillance activities including risk analysis, field actions, Periodic Safety Update Reports and communicating with authorities.
Take the lead or participate in cross-functional and global projects such as development of global Getinge procedures.
Within your area of expertise support the organization in topics related to standards and standardization and continuously improve our processes.
Qualifications
For this position, you have experience within QA/RA and/or R&D from the medical device industry. Experience from regulations and standards, such as QSR, MDD/MDR, ISO13485 and IEC60601, is expected. You have a Master's degree or corresponding education, in a relevant field together with fluent proficiency in English (our corporate language), and preferably Swedish.
We also believe that you, in addition, have worked in or with several areas of electrical medical devices, such as development, production, product management, customer support and complaints.
In this recruitment we are looking for someone that have the personal skills that promotes and develops a cross country and cross site cooperation. Your personal attributes will be of great importance! As a person you are accurate, action-orientated, driven, communicative 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.
About the company
Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise 'Passion for Life' close to heart.
If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world's most respected and trusted medtech company.
Ersättning Monthly
Så ansöker du Sista dag att ansöka är 2023-07-30
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "201441020".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Randstad AB (org.nr 556242-1718)
Arbetsplats Randstad
Kontakt Peter Janson
peter.janson@randstad.se +46766287150 Jobbnummer 7915238
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