Risk Manager Med Tech
Dfind Science & Engineering AB / Kemistjobb / Stockholm
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Do you want to develop in a growing company that continuously strengthens its position through innovative products? Do you want to work with products that improve patients' lives in collaboration with some of the world's largest pharmaceutical companies? Are you passionate about making a difference?
Then this is the right position for you!
SHL Medical is a leader in the design, development, and manufacturing of advanced drug delivery devices such as auto injectors, pen injectors, and inhaler systems. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices to effectively deliver their drugs. These self-administered devices can empower patients by allowing them to take their medications in the comfort of their homes or under the supervision of their healthcare providers.
SHL Group AB in Nacka Strand now wants to strengthen our Risk team with another full time employee.
The role:
As a Risk Manager at SHL you will be part of the QA/RA&C/RM group which consists of 8 highly skilled employees. The position is cross-functional and you will be working with both internal departments and Customers.
• The main responsibility is to establish the Risk Management File for both internal and external projects. This includes, but is not limited to, establishment of the Risk Management Plan, Hazards identification, Risk Assessment and summary of all performed Risk Activities.
• You will work in close collaboration with e.g. Project Managers, Design Engineers, Test department, Quality Assurance and Regulatory Affairs & Compliance.
• Close contact with Customers is also necessary for the position
• You will be responsible for maintaining the Risk Management File, which means close collaboration with our Taiwan office.
• You will be responsible for internal and external audits (e.g. Customer audits, Notified Body audits) for your projects
• There may be potential for travels to Customers and our various SHL sites.
Minimum experience:
• At least 10 years of work experience, with at least 3 years within regulated industries.
• Good knowledge of standards interpretation, e.g. International Organization for Standardization (ISO) standards
• Understanding of Good Documentation Practice (GDP).
• Excellent communication skills
• Good knowledge of using Word/Excel
• Experience in establishing, reviewing, and approving quality systems documentation.
• Fluent in English, both oral and written skills
Preferred experience:
• Bachelor's degree in Engineering, Science, or similar technical degree
• Good knowledge in Risk Assessment for Medical Devices
• Experience with working with pharmaceutical companies
• Good knowledge of specifically ISO14971:2012 and ISO 13485:2016
Who you are:
We see you as a positive and committed person who has the ability to plan and structure your own work. You are a team player who takes responsibility and likes to communicate with persons both internal and external.
Information & Application:
In this recruitment SHL is collaborating with Dfind Science & Engineering. Please contact recruitment consultant Ellinor Crafoord, +46-733-434502, for questions. Please submit your application in English at
www.dfind.se as soon as possible. We will evaluate applications continuously.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-10-04ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-10-15
Ange följande referens när du ansöker: 201076945
Klicka på denna länk för att göra din ansökanKontaktEllinor Crafoord
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
10724 STOCKHOLM
KontorsadressRegeringsgatan 65, 10724 STOCKHOLM
Jobbnummer 3732239
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