Regulatory Affairs Manager to Breas Medical
PSPartner / Organisationsutvecklarjobb / Göteborg
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hela Sverige BREAS Medical is a leading manufacturer of home respiratory ventilators and sleep apnea products for the global home healthcare market sold in more than 40 countries. The company was founded in 1991 in Gothenburg and today employs 140 people in nine countries and operates a manufacturing/office facility in Mölnlycke, Sweden. Breas Medical is a portfolio company of PBM Capital Group. Breas mission it to be at the Heart of Breathing by producing robust and innovative products that care for the lung, in order to improve outcomes and quality of life of the individual patient.
BRAES Medical group is in a very interesting phase as the company recently left GE Healthcare and is now a stand-alone-company with new owners. All processes are being worked through to be leaner and more agile, as well as ensuring the high quality needed in a medical device company. At the same time the company is growing very rapidly.We can offer you a fast changing environment with a very dedicated team. We are all very proud of offering great products and a renowned service level to a global market. Mölnlycke is the home base for everything from R&D to manufacturing and service as well as all the other functions. This offers a great overview of the whole process and being involved in the very core of the business. Visit
www.breas.com for further information.
Purpose of the role
We are seeking a Regulatory Affairs Manager to join our Team in Mölnlycke, Sweden. Reporting to the SVP, Global QA & RA in USA this role works with most departments within Breas Medical including working in cross-functional project teams. In the operational daily work you will be part of the local QA organisation. This role is responsible for assuring that our products will be approved by regulators globally and that our development projects reach our compliance standards. This position offers a great opportunity to work with and improve world class med-tech products in a challenging regulatory environment with high standards and ambitions.
We are 80+ colleagues in Mölnlycke who enjoy being part of a close team and have the satisfaction of developing products making a real difference in people's lives. The company has high ambition and exciting growth plans combined with being in a nice size where everything from R&D to production is active at the headquarters in Mölnlycke. In that way you get a good overview of the whole company and everyone is encouraged and involved in contributing with our success.
Job description
• Develop regulatory strategies and plans
• Provide regulatory support to project teams in R&D and marketing, with respect to regulatory expectations and documentation needs
• Ensure product modifications are reviewed and assessed from regulatory standpoint.
• Contributes to distribution of information for new and changed regulations, and provides support for their implementation in cooperation with QA
• Is responsible for timely execution and maintenance of regulatory registration for new and existing products.
Key Requirements
• University degree in science
• Five years experience in Regulatory Affairs in a medical device company
• Good knowledge in international medical device regulation, specifically EU, and international/ European standards
• Knowledge in Design Control requirements
• Used to collaborate with both internal and external stakeholders
• Desirably having experience in a medical device environment working with electromechanical devices including software
• Excellent skills in English and Swedish both written and speaking
Personal skills
As a person you have the ability to learn and keep up to date with new and changing regulations, team working skills, project management skills. You pay attention to details and concern for standards and accuracy and have a problem solving attitude. You are used to working in an international environment in multicultural teams.
You are a good planner and organizer and have the ability to establish fruitful relationships and maintain networks as you will be the link between R&D and marketing projects.
Application and Contact
This recruitment is managed by PS Partner. If you find the role challenging and interesting, please apply through
www.pspartner.se Interviews will be held continuously. If you have any questions regarding this position please contact Johan Sjöberg 0761-709851 or by mail
johan.sjoberg@pspartner.seVaraktighet, arbetstid
Heltid -
Publiceringsdatum2015-05-28ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2015-06-14
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AdressPSPartner
SÖDRA HAMNGATAN 25
41114 GÖTEBORG
KontorsadressSÖDRA HAMNGATAN 25
Övriga kontaktuppgifter Jobbnummer 2314998
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