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Regulatory Affairs Manager

Organization
DNA Script
Job Location
279 East Grand Avenue, Suite 440
South San Francisco, CA 94080
United States
Job Description

The role

Become part of our Quality & Regulatory Team and help us in building Regulatory Compliance for European Union & USA.

 

Responsibilities

• To prepare Technical Files in compliance with IEC 61010-1, IEC 61010-2-012, IEC 61010-2-08, IEC 61326.

• To provide Support in preparing Technical Files in compliance with, RoHS and WEEE, and REACH.

• To provide Support in making compliance with Machinery Directives, Directive 2014/35/EU, Directive 98/79/CE, Regulation 2017-746.

• To prepare DOC (Declaration of Conformity) for self CE & compilation of technical file.

• To support in preparation of Risk Management File & Device Master Records in compliance with 21 CFR 820 & ISO 13485.

Requirements

Qualifications and experience

Essential

•             Bachelors’ or Masters’ Degree in Medical/Biotech Engineering, Pharmacy or equivalent.

•             3-5 Years of experience in Regulatory Affairs.

•             Experience in Preparing Technical File.

•             Familiarity with Post Market Surveillance & export submission is a plus.

•             Strong interpersonal skills.

•             Good command of the English language.

 

 

Miscellaneous

•             Job located in South San Francisco (USA)

•             Start date: ASAP

How to Apply

Send your resume to: [email protected]

About Our Organization

DNA Script is a leading company in manufacturing de novo synthetic nucleic acids using a proprietary enzymatic technology. DNA Script's approach leverages nature's billions of years of evolution in synthesizing DNA to set a new standard for how nucleic acids are made and accelerate the adoption of synthetic biology across diverse disciplines such as biopharma, sustainable chemistry and data storage. DNA Script’s first product will be a DNA printer. On course to hit the shelves in 2021, this benchtop instrument will enable researchers to target and program specific areas of the genome.

To date, DNA Script has raised over $100M of financing, mostly through leading investors such Casdin, Agilent, Danaher, LSP, Bpifrance, Illumina Ventures, Merck Ventures, Sofinnova Partners, Kurma Partners, Idinvest.

DNA Script has its research facility headquartered in Paris, France, and is in the process of expanding its commercial and development teams in South San Francisco.

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