Senior Regulatory Affairs & Compliance Engineer

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Main purpose of role

You will responsible for ensuring the operations effectiveness of RA activities throughout the organisation.

Key tasks

* Deputise for Regulatory Affairs and Compliance department in the absence of reporting Manager as required.

* Maintenance and implementation of policies and procedures.

* Tracking regulatory changes (standards/directives/guidance documents) and managing the initiation of applicable updates to relevant processes.

* Dissemination of the regulatory changes throughout the organisation.

* Contact as appropriate with regulatory authorities.

* Coordinate and manage regulatory projects as required.

* Review change documentation for regulatory impacts.

* Review and approve labelling, marketing literature and claims substantiation compliance.

* Working closely with the NPI / R&D team, to lead regulatory input in assigned R&D projects and pre-launch reviews (project management and member of teams).

* Preparation and maintenance of Technical Files & associated documentation, (e.g. 510(k)s and notes to file.)

* Support and coordinate the risk evaluation activities.

* Support and coordinate field correction process as required.

* Mentor and develop other members of staff in Regulatory and Compliance requirements.

* To operate as a member of the RA team with a mandate to promote regulatory sound business practices throughout the organisation.

* Ensure compliance to all processes related to the requirements of Regulatory Affairs department. Working with the relevant department to ensure the maintenance of Technical Files, Device master files & associated documentation,

* Working with program teams in identifying regulatory requirements early in the new product development process. Participates as a member of a product development team to provide regulatory support to the project. Ensuring that they meet the regulatory requirements of the target markets

* Maintain an up to date awareness of regulatory issues and expectations of EMA, FDA, and other global regions as required. Process changes to regulations as applicable.

* Any other tasks that sits outside your current role from time to time to support the activities of the business.

Qualifications, skills and desirable experience

* You will have an Engineering Degree or equivalent experience.

* You will have experience working in a regulated environment preferably with medical devices.

* Knowledge of the Medical Devices Directive 93/42/EEC is essential; knowledge of FDA QSR regulations would be desirable.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales