QA/RA Manager

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To ensure products are developed, manufactured, and sold in accordance with the Company Quality Management System and Medical Devices Directive EN/93/42/EEC (as amended).

Interact and assist Board members to deliver company's product and market strategy. There will be a mixture of QA/RA and Product development duties combined in this role.

General Responsibility;

* Co-ordinate and manage all new product development and line extensions

* Packaging design and validation

* Design/ procure product delivery devices

* Manage all sub-contractors engaged in operations/ manufacturing support activities.

* Engage with end users in controlled/ documented processes to validate product attributes and all key development decision points.

* Deliver agreed operations/ product development strategy as defined in the annual business plan.

* Management and implementation of company Quality Management System

* Preparation of Technical File and DESIGN Dossier for regulatory submissions.

* Constructing User requirements

* Developing Design Inputs

* Understanding of how to construct a dossier to respond to Essential Requirements Checklist

* Manage company's relationship with Notified Body

Essential Requirements.

* Graduate in science, engineering or business discipline

* 5+ years' experience in senior Operations / Quality role in Medical Device.

* Medical Device experience, preferably Class III implantable.

* Well-developed understanding of the requirements of ISO13485 and EN/93/42/EEC

* Product development/technical management

* Demonstrable ability to successfully work in a small team

* Completer-finisher behaviour

* Experience of FDA 510(k) submissions valuable

* Familiar with the requirements of ISO10993, ISO11137

My client is now shortlisting for interview so if you believe you have the correct experience then please send me your CV and I will be in touch shortly.