Product Development Senior (ISO13485)

Laboratories

Laboratory Team

Medical Devices Manufacture

Berkshire

£50,000 - £75,000

Manufacturer

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 maia@zenopa.com , 01494818021

Locations

Basingstoke

Bracknell

Newbury

Reading

Wokingham

Previous Listing

Date Updated

31 May 2022

Job reference

69643

We aim to operate and maintain the following set of core values

In house, contracting department.

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We liaise on your behalf

Required equipment, e.g. cars, laptops, mobiles, we negotiate with the employer source and manage these on your behalf.

Solid Industry Relationships

Our recruitment teams have built relationships with some of the UK’s most prestigious pharmaceutical companies

High Success Rate

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Systems that work for you

As an ISO 9000 organisation we have fully defined systems that are regularly audited. You can be assured we consistently following processes that deliver for all.