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Role Filled

Product Development Senior (ISO13485)

Laboratory Team
Medical Devices Manufacture
£50,000 - £75,000

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 ISO’s, SOP’s and other critical laboratory documentation.

You’ll 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.

Role Requirements

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 Specifications

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


Previous Listing
Date Updated
31 May 2022
Job reference
Full Time
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This role has been filled