Medical Device Technical Expert in Risk Management/Pharma (Ref.Nr. HS2

MEDICAL DEVICE TECHNICAL EXPERT IN RISK MANAGEMENT/PHARMA

We are looking for a Technical Expert in Risk Management, for one of our Customers in Basel.

MAIN TASKS

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Ensure timely completion and quality of the assigned risk management files.
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Lead specific risk management activities within projects, as agreed with project leaders
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Facilitate development and completion of risk assessments.
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Ensure compliance with ISO 14971 in all development projects assigned
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Conduct and provide guidance on the use of risk analysis for Use, Products, Components and Processes.
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Ensure compliance with regulatory and normative guidelines focusing on medical device risk management
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Guide internal and external functions on creating, reviewing and approving medical device Risk Management Files.
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Work with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements.
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Apply FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects
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Author the documentation in the medical device risk management file.

REQUIREMENTS

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At least 5 years of experience in device development of parenteral delivery systems, eg, drug/device combination products with main focus on medical devices for parenteral administration.
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Experience in generating DHF documentation.
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Excellent technical writing skills (eg, Design Controls)
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Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
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Experience in Product Design and Design for Manufacturing
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Good technical knowledge of primary containers development
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Good technical knowledge of autoinjector development

WORK LOCATION: Basel

START: June 2018 to December 2018 (plus possibility of extension after the 6 months)

DURATION: 6 months +

WORKLOAD: 100%

SALARY: to be discussed

LANGUAGE: English

REF: HS2460

To learn more about this opportunity please send your CV ASAP in Word format to Brine SA

BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:

Financial services sector, especially banks and insurance companies

Pharmaceutical industry

Government and services sectors

BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management and IT-consulting through to software development and project implementation.

IT - RESOURCES

We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:

Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.

Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA

Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.

BRINE SA is ISO 9001:2008 certified since 2014