Permanent

Quality & Regulatory Manager

  • LocationLancashire, North West, England
  • Salary
  • SectorCompliance
  • Job RefBH-97745
  • ContactWill Godfrey
  • Published11 days ago
Will Godfrey

Will Godfrey

Billing Manager

Übersicht

This is a fantastic opportunity for a Quality and Regulatory Manager to join a Global Medical Device company based in Lancashire. Leading a team within QA/RA this will suit someone with a strong background in Medical Devices, people leadership, Regulatory Affairs and Quality Management.

Key Responsibilities & Activities

  • Responsibility for development, implementation and continued improvement of the quality management system and regulatory documentation.
  • Ensure a robust supply chain is in place to support product conformity.
  • Development and maintenance of Technical Documentation for regulatory purposes.
  • Managing the internal, supplier and 3rd party audit programmes.
  • Liaison with external bodies, customers and suppliers.
  • The UK Quality & Regulatory Manager is the appointed Management Representative.
  • Responsible for working within Health, Safety and Environmental standards and procedures.
  • Aptitude for team work and results orientation.
  • Aptitude and ability to promote continuous improvement in a busy manufacturing environment.
  • Experienced in statistical analysis techniques and application.
Job Qualifications, Skills & Attitudes
  • Ability to plan and organise work load according to priority, business needs and strict deadlines.
  • Very good verbal and written communication skills.
  • Attention to details and excellent visual awareness.
  • Ability to communicate effectively with different stakeholder groups on site.
  • Ability to present data and information to senior management.
  • Experience of multi-disciplined management system incorporating ISO 9001, ISO 13485, ISO 14001, ISO 45001 & ISO 50001.
  • Experience of managing a multi-functional quality and regulatory team.
  • Experienced in hosting notified body, and customer audits
  • Experienced internal and supplier auditor.
  • Experience of regulatory processes including MDD 93/42/EEC, MDR 2017/745, CGMP as detailed in 21 CFR 820, NIOSH 42 CFR part 84 and PPE Directive 2016/425.
  • Risk Management according to ISO 14971.
  • Minimum 5 years’ experience in a Quality and Regulatory role.
For immediate consideration please forward your most up to date CV

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

Check us out on our website and LinkedIn for more roles.

We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU



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    Regulatory Affairs Engineer

    UK

    £45000 - £55000 per annum

    Austin Vita are pleased to offer an exciting opportunity for a hands on Regulatory Engineer to join our client, an innovative medical device business who design, develop and manufacture a range of devices for global markets based in Buckinghamshire. This will be a site based role so suit someone who loves working in a Team and rolling up their sleeves to the broad range of tasks and challenges.

    The opportunity comes at a time of site expansion and natural growth within the Quality & Regulatory department, and your responsibilities will include:

    • Working with internal departments and external regulators, suppliers and customers with a broad remit to ensure the ongoing product and systems compliance to the applicable regulations and standards.
    • Assisting in the maintenance and review of technical product files and assist in the continued transfer to the MDR.
    • Working with the design department to ensure ongoing regulatory compliance of current and new products.
    • Collaborating with a team of design engineers to produce a variety of technical documentation (such as essential requirements, risk assessments, test reports, etc).
    • Producing documentation in compliance with the relevant regulatory standards.
    • Working with internal departments, Competent Authorities, other national authorities and our Notified Body on product and company registrations.
    • Working in conjunction with the Sales department to provide the necessary documentation to support the registration of our products in international territories.
    • Assisting in the actioning of regulatory requirements associated with NCRs, customer complaints, CAPA reports etc.
    To be successful in the role, we are looking for candidates with:
    • Relevant experience with MDD/MDR (essential).
    • Experience of interpreting and implementing standards and regulations.
    • Broad background in regulatory compliance of systems and products within a QMS.
    • Broad background in electro/mechanical products highly desirable, along with an understanding of the impact of regulatory requirements.
    • Experience of medical standards and European/ FDA regulations highly desirable.
    • Experience of medical device manufacturing and medical standards highly desirable.
    • Familiarity with translation/localisation processes may be useful.
    Qualifications:
    • Preferably degree educated in a technical subject, such as Engineering, or in a another subject with experience of technical industry.
    You will be rewarded with a great salary and benefits including company bonus, so if this sounds of interest please apply ASAP.

    Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

    Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

    Check us out on our website and LinkedIn for more roles.

    We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU

    Regulatory Affairs Team Leader

    UK

    Austin Vita are delighted to be offering a fully remote, permanent, job opportunity for an experienced Medical Device Regulatory Affairs professional to join a well established Regulatory Group as a Team Leader working on Class III Devices for a global manufacturer.

    Responsibiliites:

    • Preparation and review of regulatory documentation and submissions for product approval.
    • Development of regulatory plans/strategies for new products and changes to existing products.
    • Participation in Design Control, Risk Management and Post Market Surveillance activities.
    • Production and review of design dossiers, technical files and change assessments.
    • Review and preparation of regulatory paperwork in accordance with International standards and new regulations.
    • Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations.
    • Facilitate compliance with Vigilance System.
    • Provide regulatory input to functional groups as required.
    • Participate in review of RA procedures.
    • Review and approval of validation, protocols and reports.
    • Mentorship of RA Associates
    For immediate consideration please forward your most up to date CV

    Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

    Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.

    Check us out on our website and LinkedIn for more roles.

    We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact privacy@austinfraser.com Austin Fraser International Ltd is registered in England: 14971372 Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU