Senior Regulatory Affairs - Medical Devices - Hampshire

PRIME RESPONSIBILITIES:

In coordination with and under the supervision of the P&RAD, implement agreed strategies for compliance with applicable regulatory requirements. This includes preparation of documents, assessment of regulatory requirements and performance of the following tasks:

* Develop and maintain Essential Requirements/Principles checklists.
* Alongside the PDRCE, maintain the compliance library and the list of applied standards. Review the impact of changes to standards and help manage any required conformance and engineering change activities.
* Write and maintain (update and review annually) risk assessments and support the maintenance of the device risk management files and overall risk management activity across the product lifecycle (e.g. to ISO14971).
* Write and maintain product submissions to relevant regulatory agencies (CE Notified Body, FDA,HealthCanadaetc.).
* Manage global product listings and registrations and assist management of the approved market log.
* Record complaints and manage their response and closure. To support the P&RAD and QSM with vigilance reporting, field corrections and recalls.
* Support CAPA system (complaints, returns, non-conformances, deviations, corrective actions), system alongside existing P&RAD, QSM, QE, PE etc.
* Manage post market surveillance activities.
* Manage collection and presentation of clinical data.
* Assist the PDRCE, P&RAD, IAM and the TM in the generation, approval and management of labeling, labels, training materials, marketing materials and artwork. This includes, briefing, drafting, creating and validating any labeling.
* Assist the QSM with the calibration management activities.
* Perform EEE reporting under the WEEE Directive.
* Perform other technical and regulatory activities as required.

QUALITY OBJECTIVES:

* To ensure that they are appropriately trained for the task they are to perform.
* To ensure that the activities they conduct are in accordance with the quality system SOPs and company quality policy.
* To ensure that they maintain and continuously improve their understanding of the international regulatory systems that apply.

KEY TASKS/DUTIES:

* Creating necessary documentation to achieve the areas outlined above.
* Investigating / assessing issues in order to achieve the areas outlined above.
* Planning (including interfacing with colleagues) and executing such plans in order to achieve the areas outlined above.

Device, Devices, Medical Devices, Medical Device.

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