Permanent

Regulatory Affairs Engineer

  • LocationBuckinghamshire, South East, England
  • Salary
  • SectorCompliance
  • Job RefBH-94222-2
  • ContactWill Godfrey
  • Published28 days ago
Will Godfrey

Will Godfrey

Billing Manager

Übersicht

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



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    Senior Regulatory Affairs Specialist

    UK

    £50000 - £60000 per annum

    The Senior Regulatory Affairs Specialist is responsible for ensuring medical device regulatory compliance with national and international legislation for projects, product and new market clearance. You will manage specific regulatory objectives to meet the company’s Strategic Plan and Department Operational Objectives. Assisting and sometimes deputising for the Head of Quality and Regulatory Affairs in all matters relating to compliance with EU and international Medical Device regulation and legislation.

    Responsibilities:

    • Manage regulatory affairs objectives set by the SLT to meet the company’s Strategic Plan
    • To take the lead in all matters relating to regulation and applicable legislation
    • Development, management and maintenance of the company’s Technical Files and Design Dossiers
    • Responsible for the maintenance of Product Schedules with device classifications and allocating new GMDN codes.
    • Lead the Regulatory Affairs Team in new country product application to market including country specific technical report generation and submission.
    • Administer regulatory aspects of new product development initiatives and notify applicable changes to the Notified Body
    • Liaise with the company’s notified body / competent authority and oversee international submission processes. Host Notified Body Technical File audits.
    • Provide regulatory advice to other departments and Project Teams as and when required.

    Skills/Experience:
    • Degree educated or equivalent in a life science or engineering discipline. A Member of the Organisation of Regulatory Professionals (MTOPRA)
    • At least five years’ experience in a life science regulatory environment ideally working with Class III Devices.
    • An in-depth knowledge of the international regulatory requirements for placing medical devices in UK, EU, North America, South America, the Baltics and AsiaPacific markets.
    • An in-depth knowledge of Management Systems in particular ISO 9001, ISO13485, RDC 59/2000, ISO 14001, OHSAS 18001, 21 CFR Part 820 & Part 11
    • Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed time scales. Ability to write detailed reports.
    • Strong leadership and influencing skills
    • Capable of working on own initiative as well as leading successful cross functional teams.
    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

    Head of Quality and Regulatory Affairs

    UK

    As Head of Quality and Regulatory Affairs you will manage the Quality, Regulatory and Clinical Teams for an exciting Medical Device Manufacturer working on Class III Devices. Giving overall guidance and leadership to QA/RA functions including product registration, complaint handling and reporting, internal/external auditing of the quality systems and supporting R&D and Marketing.

    Pivotal in developing company policies, procedures, and training to ensure efficient and effective operation of the companies quality system and regulatory requirements. Serving as the Quality System Management Representative and Medical Device Person Responsible for Regulatory Affairs.

    Responsibilities:

    • To oversee and continually review the quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause and appropriate procedures are developed and fully implemented. To ensure a sustainable compliant quality management system that fully supports the current and future commercial needs of the business.
    • Ensuring complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with the company QMS.
    • Ensure effective data management systems, policies, processes and programmes to provide assurances of ongoing statutory and regulatory compliance and delivery within budgets whilst providing for a high level of internal and external customer satisfaction.
    • Remain up to date with impending changes and developments regarding regulatory and compliance requirements as well as evolving best practices in compliance control.
    • Develop, manage and maintain the company’s device family technical files and product specific design dossiers ensuring compliance with the relevant regulations.
    • Develop and maintain an excellent understanding of the company’s procedures and products.
    • Keep up to date with changes in regulatory legislation and guidelines together with customer practices and changes to device standards and testing (globally)
    • Provide sound advice to management throughout the development of new product and product enhancement submissions, to ensure that the principles of the submission accurately reflect the regulatory requirements to aid timely product introductions and certificate renewal processes.
    • Liaise with the company’s notified body / competent authority, & oversee international submission processes
    • Collaborate with the Regulatory Affairs personnel from distributors and partners, providing assistance for the maintenance of international product registrations.
    • Ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organisation
    • To be the Person Responsible for Regulatory Compliance (PRRC) as defined in Article 15 of the MDR 2017/745.

    Skills/Experience:
    • Degree educated, or equivalent, in a life science or engineering discipline
    • At least five years’ experience in medical device regulatory environment.
    • An in-depth knowledge, and appreciation, of the regulatory requirements for placing class III medical devices on the European market. Experience of North America, South America, Asia-Pacific markets would be desirable.
    • Strong leadership and influencing skills
    • Experience building a high performing team, managing the performance of team members with varying levels of skill and experience, and providing support and mentorship.
    • Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed time scales.
    • Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
    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

    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