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Risk & Compliance Officer

Medical Devices & Equipment
Regulatory & Compliance
Operations/ QC
Slough
£50,000 - £60,000
Endoscopy

Role Overview

The role will involve being responsible for identifying, analysing, remediation actions and documenting corporate risk to ensure the company’s business practices comply with all applicable domestic and international legal and regulatory requirements and ethical standards. You will also manage regulatory change when required and ensure that all employees and stakeholders comply with applicable rules and regulations through the provision of guidance, SOP’s, advice and training

Company Information

Our client are an independent, family-owned global MedTech company that ambitiously think in generations instead of quarters to improve patients’ lives around the world. Their medical specialities predominantly lie within the surgical space, including: urology, endoscopy, ENT, Gynaecology, Neuro, Gastroenterology etc

Role Requirements

Maintain a compliance framework that promotes a proactive compliance culture, identify and manage the regulatory risk relevant to the business the support the business by the operation of an effective compliance control environment.
The compliance framework will include completion of risk assessments, maintenance of key compliance registers (including breaches, conflicts, and compliance complaints) and a documented compliance training program.
Conduct periodic and themed reviews across the business and with applicable internal and external stakeholders, including suppliers.

Person Specifications

-Solid understanding of ISO 13485
-Good understanding of Medical Device Regulations, MHRA regulations and guidelines for placing and managing medical devices in the UK market
-Proven compliance training material preparation and presentation skills
-Good understanding of the UK healthcare industry, including the legal and regulatory environment within which it operates
-Experience in the application of the COSO Enterprise Risk Management Framework
-Experiene in audit or inspection of process, systems and vendors

Package

Generous pension
Private Medical & Medical Cash Plan
34 days holiday

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    Further Details/Cover Note

    Locations

    Maidenhead
    Marlow
    Slough
    Windsor
    Date Updated
    10 Jul 2024
    Job reference
    73316
    Categories
    Full Time
    Take Experience
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    Why Zenopa?

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

    Group people cartoon
    01
    In house, contracting department.

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    02
    We liaise on your behalf

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

    03
    Solid Industry Relationships

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

    04
    High Success Rate

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    05
    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.