The role is covered in the following locations: Reading

Role Overview

Are you looking to join a leading company within Medical Devices, and the opportunity to play an integral part in the design process of quality products?

Zenopa have partnered exclusively with a market leader within Consumer Health products to recruit an experienced scientist with a strong understanding of ISOs, SOPs and other critical laboratory documentation.

Youll be responsible for running the design process and looking after the associated files and documents relating to the design, to guide products to the manufacture process. The role combines technical expertise in product manufacture with ISO13485 reg. knowledge.

Key Duties and Responsibilities

In this role you will:
Develop and maintain Design History Files, Risk Management Files and Usability Engineering Files
Maintain robust Design Control, Risk Management and Usability Engineering processes in line with relevant standards e.g. ISO 13485, ISO 14971 & global regulatory requirements
Partner with multifunctional colleagues in Reading, other R&D and Manufacturing sites to identify changes to existing medical devices & obtain updates from Post Market Surveillance & update Design Control and Risk Management documentation accordingly.
Lead Design Control and Risk Management portions of external Notified Body audits both on site and by answering questions received from their offsite documentation reviews.
Partner with Regulatory Affairs, Safety, Safety Surveillance, QA, Manufacturing and the full R&D and Product Supply community to build devices capability and continuously strengthen our ability to operate in an important and profitable category.

Person Specification

\red5\green99lue193; What we are looking for:
Degree or PhD in Life Sciences, Physical Sciences or Engineering
Strong technical background in formulated health care or personal care products
Familiarity with EN ISO13485:2016, Medical Devices and/or OTC Medicines requiring dossier approval to market.
Extensive experience in a health care GMP environment
Geography: Ability to work permanently in the UK.

We look forward to receiving your application and for any further questions or details please get in touch with myself at , 01494818021

31 May 2022

Maia D'Souza

Scientific Recruiter 01494 818021

Tom Summerbell

Head of Lab Recruitment 01494 818 037

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