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Technical writer pharma/med dev

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The company

Our client is a professional Pharmaceutical and Medical Devices organisation, based in Noord-Brabant Netherlands. Multinational in Pharmaceutical products.

Role description

Days: For 2-3 days a week
Hours/week: 20
Start date: ASAP
End date: minimum 30-JUN-2019 with possible extension to 31-OCT-2019 or 31-DEC-2019 depending on regulatory timelines
Freelancers are welcome!

Mission of the project: Move SaMD from MDD to MDR

Responsibilities

Our clients CE-marked SaMD (Software as a Medical Device) fall under the new Medical Device Regulation (MDR). We are looking for a specialist to assist in this global project.

Requirements

• Background in regulated pharma environment with good understanding on regulatory and compliance requirement in software medical devices, and CE marking requirements
• Trained in ISO 62304
• Trained in MDD to MDR with a recognized regulatory body such as BSI, TÜV, NEN
• Technical writer with excellent documentation skills
• Affinity with requirement documentation needed for Design History file
• Good command of English language, verbal and written

Other information



Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Thomas Aelen.

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SIRE Information Technology®

Ref. number: 45521
Listed by: SIRE Information Technology®
Listed on: 30-11-2018
Country: The Netherlands
Region: Noord-Brabant
Employment: Freelance
Expertise: 6 - 10 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Pharmaceutical
Specialisation: Business Intelligence

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