Regulatory Affairs Specialist to innovative MedTech company
C-Rad Positioning AB / Apotekarjobb / Uppsala
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hela Sverige Visa alla jobb hos C-Rad Positioning AB i Uppsala We are looking for a Regulatury Affairs Specialist to strengthen our team.Your contribution to our success: You are responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files.Qualification: Minimum of 2 to 3 years regulatory or equivalent experience within a Medical device or pharmaceutical company, CRO, or similar organization Write, analyze, and edit technical documents to support country- specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe. Work with other departments and communicate the submission requirements when documents are needed for regulatory submissionExperience from supporting external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance Knowledge on maintenance and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required. Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills Competencies: Excellent written and Verbal communication skills with the ability to listen, articulate and advocate Proactive, high performance, result oriented and manage projects with ethical integrityTechnical system skills (e.g. MS office applications, databases, efficient online research)Manage multiple projects and deadlines Ability to identify compliance risks and escalate when necessaryDemonstrate both creative and critical thinking skillsFluent in English and Swedish What we are offering for you: Interesting position in an innovative, fast growing company Young team within a global positioned organization Short decision-making processes supporting an efficient working environment High level of individual responsibility and attractive possibilities for self-development Our core values are: Professional, Organized and Honesty Company:C-RAD is a global Medtech Company with its headquarter in Uppsala. We are developing and selling innovative solutions for cancer treatment. The focus is on a cutting-edge technology for patient positioning, monitoring and imaging within radiation therapy. We are market leader in our field and have established a global presence. C-RAD is a stock listed company at NASDAQ Stockholm.Next steps:Candidate assessment is done on a rolling basis.If this vacancy is attractive for you, we are very much looking forward to receiving your application:Leo Glatkowski Director Quality and Regulatory Affairs C-RAD Positioning ABBredgränd 18 SE-75320 Uppsala,
SwedenLeo.glatkowski@c-rad.com www.c-rad.comPubliceringsdatum2019-04-04Så ansöker duSista dag att ansöka är 2019-05-04
Ange följande referens när du ansöker: Regulatory Affairs Specialist
FöretagC-RAD POSITIONING AB
KontorsadressBREDGRÄND 18
Jobbnummer 4711195
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