QA/RA Manager
Dreamwork Scandinavia AB / Administratörsjobb / Lund
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hela Sverige <b>About the job</b>
Here is an opportunity to join a company with great products and probably the best location in Lund. On the 19th floor with an awesome view you will work with quality assurance, regulatory affairs, pre- and post- markets compliance activities on a daily basis.
The team members of Exini are driven by the vision and passion to help improve the lives of prostate cancer, pheochromocytoma and paraganglioma patients and their families. You will get to work on exciting stuff and work together with our team of highly qualified professionals who love what they do - making lives better!
<b>About the company</b>
Exini Diagnostic. is focused on developing innovative medicines and other technologies to target and treat cancer. The Company's pipeline includes: 1) therapeutic agents designed to precisely target cancer (AZEDRA® and 1095), 2) PSMA-targeted imaging agents for prostate cancer (1404 and PyLTM), and 3) imaging analysis tools. EXINI Diagnostics AB, a wholly-owned subsidiary based in Sweden, is focused on developing sophisticated software (artificial intelligence) that assists physicians and patients in visualizing, understanding, targeting, and treating cancer. Progenics' first commercial product, RELISTOR® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with Valeant Pharmaceuticals International, Inc.
<b>More about the job</b>
Exini is a global organization with offices in the U.S. (New York City) and Sweden (Lund). You will be positioned in Lund but also work with colleges in NYC. English is your working language even if Swedish is mandatory for your daily work in the office in Lund.
Typically work tasks for the AQ/RA Manager can be:
• Control and maintenance of the Quality Management System (QMS) including implementation of new/changed regulations, standards and guidelines
• Maintaining technical documentation for software as a medical device products according to applicable regulations, standards and guidelines
• Preparing and filing premarket submission in the EU and US markets (CE marking, 510(k))
• Preparing and participating in internal as well as external quality audits
• Planning, overseeing and participating in Risk Management Activities
• Promote awareness of applicable regulatory requirements and quality management system requirements to top management and throughout the organization
• Work on product releases and product registrations
• Overseeing the handling of complaints, non-conformances and communicating with the regulatory bodies in compliance issues
<b>Your profile</b>
To be successful in this role we think you have university degree in Quality, Engineering or similar. Regulatory experience from medical is a big plus, ideally IDE, PMA and or FDA510(k). You must be able to discuss, understand regulatory strategy for emerging product offerings.
Key competences:
• Getting Results Communication
• Teamwork and Collaboration
• Planning and Organizing
• Strategic Thinking
<b>Application</b>
Please submit your application by registering your CV and your application on
www.dreamwork.se as soon as possible since the search- and selection process is ongoing.
If you like further information, please contact Jonas Leijon, phone: +46 40 660 12 09
About Dreamwork
We are People Management consultants. Instead of having a traditional recruitment and staffing agenda we work harder to match our candidates with our customers' company culture. We have a close relationship with LinkedIn and our recruiters and researchers have certifications in the LinkedIn recruiter modul. Two times, we have been appointed as a Gasell company by Dagens Industri and have the same amount of times been nominated for EY:s "Entrepreneur of the Year". Dreamwork was founded in 2006 and we have delivered staff related services at over 130 cities in Sweden, from Kiruna in the north to Ystad in the south. We are ISO-certified according to ISO 9001.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2020-01-10ErsättningFast lön
Så ansöker duSista dag att ansöka är 2020-02-14
Klicka på denna länk för att göra din ansökanFöretagDreamwork Scandinavia AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "5259".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Dreamwork Scandinavia AB (org.nr 556695-7600),
http://www.dreamwork.se/ Jobbnummer 5035026
Observera att sista ansökningsdag har passerat.