Regulatory Affairs Specialist to Stryker/Jolife AB in Lund
Technogarden / Kemiingenjörsjobb / Lund
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hela Sverige Main responsibilities
In the role of Regulatory Affairs Specialist you are the link between Pre-market and Product sales.Your daily work focuses on EU MDR, US QSR and other relevant regulatory requirements of the markets in which we currently sell or intend to sell our products (+50 countries globally).Main tasks include expertize in EU MDR, 510(k)/PMA, maintaining current Product registrations, initiate new registrations, knowledge in applicable EU Directives, UDI.Major duties/responsibilities:
Implementation of EU MDR
Monitoring and Maintaining current product registrations
Executing new product registrations
Product Change Notifications
UDI handling
Radio equipment registrations
Market support
Ensure compliance with applicable regulatory requirements
EU Directivesetc.)
Monitoring of changing global regulatory requirement
Maintenance and continuous improvements of the Jolife Quality Management System.
QMS-administration - handle originals, distribution and receipts.
Maintain regulatory documents library and keep it current.
Perform gap analysis for new or updated regulatory requirements
andidentify potential gaps in Jolife QMS.
Follow up of quality audits and coordinate the closure of findings.
Prepare regulatory related data for Management reviews.
The position is based at Jolife AB in Lund, a part of Stryker with global travelling 5-30 days a year. You report to the Quality & Regulatory Affairs Manager.
Qualifications
You have a University degree in natural sciences, medicine, pharmacy, engineering or another relevant discipline and at least 2-5 years of professional experience in regulatory affairs or in quality management systems relating to medical devices or similar regulated industry. You are knowledgeable and experienced in:
Regulatory Affairs (MDD 93/42/EEC, QSR etc.)
Document Control
Design Control and Risk Management (ISO 14971)
Application of standards for Quality Management System
ISO 13485 etc.)
Application of standards applicable for active medical devices
Project Management
To succeed in the role you are a driven and systematic person with solid analytical skills, fluent in writing(English) and MS Office. You have a passion for structure, processes and quality. Furthermore you are accustomed to an international environment characterized by high quality demands, regulations and standards. You are open-minded to new knowledge, work independently and take own initiatives. You are a communicative person who can transfer skills and knowledge in an informative and easy digestible way. You are clear in your message and not afraid to question if needed.
About the company
Jolife AB, a wholly owned company by Physio-Control Inc/Stryker Inc, develops and markets the LUCAS TM Chest Compression System, with related accessories for the global market. LUCAS TM is a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR). Our vision is a world in which no one dies suddenly as a result of an acute, treatable medical event. And our mission is to make Lifesaving Tools for Lifesaving Teams.
Application
For further information about the position please contact Recruitment Consultant Jörgen Björkman at Technogarden, 0739-80 83 95.
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2018-04-17ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-05-13
Klicka på denna länk för att göra din ansökanKontaktJörgen Björkman
jorgen.bjorkman@technogarden.se +46 739 80 83 95
FöretagTechnogarden
AdressTechnogarden
Scheelevägen 2
22381 Lund
KontorsadressScheelevägen 2 , Lund
Jobbnummer 4090027
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