Permanent

Senior Regulatory Affairs Specialist

  • LocationSouth Yorkshire, Yorkshire, England
  • Salary£50000 - £60000 per annum
  • SectorCompliance
  • Job RefBH-96193
  • ContactWill Godfrey
  • Published3 months ago
Will Godfrey

Will Godfrey

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Übersicht

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



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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

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    Regulatory Affairs Specialist

    UK

    This is a fantastic opportunity for a Regualtory Affairs Specialist to join a global medical device manufacturer based in the South East. The position offers hybrid working (at least 2 days per week on site) and are able to offer relocation for the right candidate.

    Benefits:

    • Annual leave that increases over your length of service
    • Flexible working hours
    • Hybrid working
    • Pension Scheme
    • Private Medical Cover
    The Role
    You will be involved in supporting change management activities, collaborating with different departments across Quality, R&D, and Manufacturing to help manage sustaining changes across the medical device portfolio, incorporating the review/approval of change requests.

    You will represent Regulatory Affairs in weekly change boards and ensure the appropriate regulatory action is taken during implementation of change. The role will also work with counterparts globally, assessing potential impact of planned changes and communicating implemented changes so experience working in a global matrix environment would be ideal.

    Other responsibilities include:
    • Generating/maintaining technical documentation for compliance to applicable regulations
    • Supporting regulatory compliance projects (EU MDR and NPD/sustaining projects for example)
    • Driving process updates and contributing to process improvement

    Experience required:
    • Medical Device Regulatory Affairs
    • University degree in a scientific subject
    • Excellent communication and organisational skills
    • Ability to work with cross-functional teams and diverse cultures
    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

    Read more