Oxford Immunotec, Inc.

  • Director, Regulatory Affairs

    Job Locations UK-Milton Park, Abindgon
    Posted Date 2 months ago(04/04/2018 2:28 PM)
    ID
    2017-1775
    # of Openings
    1
    Department
    Quality & Regulatory
  • Overview

    This position is responsible for the management of regulatory activities within Oxford Immunotec Ltd. and Oxford Immunotec Inc. in all markets, including EU, US and international.

    Primary Responsibilities

    Overall responsibilities:

    1. Regulatory Affairs (RA) responsibility for delivering regulatory approvals and clearances for T-SPOT.TB product developments, tick-borne disease and related IVD products and services.
    2. RA responsibility for regulatory strategy for selected projects in multiple markets.
    3. Ensuring US FDA requirements are met and submitting appropriate regulatory filings, supplements and pre-subs to ensure business demands are met in a timely fashion in the US.
    4. Kit and Service responsibilities including RA oversight and planning regarding site transfers, maintaining CLIA/CAP certifications, US state licenses and UK lab accreditation.
    5. Managing EU Notified Body interactions and contract management to enable transition to IVDR in the EU.
    6. Manage US FDA interactions in relation to new filings and pre-submissions, changes and PMA supplements.

     

     

    Specific deliverables for the role are:

    1. Define regulatory strategy (in both the US and EU) to ensure that eventual product approvals meet the company’s commercial needs with regards to TB, blood screening, tick-borne disease (TiBD) and related businesses.
    2. Manage all interactions with key regulatory bodies (mainly Notified Bodies, CDRH) with respect to TB, blood screening and TiBD products and services.
    3. Prepare EU, US and international regulatory submissions and manage the submissions and review process with the regulatory body.
    4. Ensure all existing EU CE Mark certifications are maintained throughout transition to IVDR and that appropriate plans are in place to secure ongoing CE certification post transition.
    5. Formulate plans to ensure Brexit implications in relation to OI’s products are resolved and mitigated in a timely fashion to preclude any associated regulatory risks that may arise (e.g.: develop and implement an appropriate Authorised representative strategy).
    6. Work closely alongside RA and QA colleagues to ensure that actions are consistent with the Company’s overall regulatory strategy and quality policy / objectives.
    7. Work with the relevant groups to ensure manufacturing/product development/scale up activities meet risk management and design control requirements; regulatory processes are followed correctly and the design history files, manufacturing batch records, quality documentation, risk assessment etc., meet FDA’s standards.
    8. Ensure ongoing Regulatory compliance post licensure / post approval.
    9. Ensure US FDA QSR / c-GMP and EU QMS are adequate to enable approval and continued approval (certification / registration) of new manufacturing sites for kit products.
    10. Support the process during MDSAP, FDA or other regulatory body inspections of US and UK sites.
    11.  Work with marketing to ensure that marketing collateral and promotional pieces are compliant with our technical data and meet FDA and other regulatory requirements.
    12. Adhere to the Company Quality Management System, including: ISO 13485:2016 and QSR’s.
    13. Work to Oxford Immunotec’s Company Values at all times.

    Qualifications

    Technical skills and abilities

    • 10 years’ experience in the development and approval of medical device (preferably IVD) products
    • 10 years’ experience in an appropriate regulatory role within med tech (IVD) businesses
    • First-hand experience of managing regulatory processes
    • Experience of having successfully gained approval for PMA / PMA Supplements, 510(k) clearance and CE Mark certification; additional experience of international registrations (especially China and Japan) would be an advantage
    • Strong background in successful management of complex, major projects of strategic importance
    • Comfortable with a dynamic and changing environment, preferably with experience in site relocations
    • Experience in manufacturing and quality functions an advantage
    • Experience of having launched products that changed clinical practice (i.e. not just “me too” products) a distinct advantage
    • Experience of launching (gaining approval and/or clearance for) diagnostic products; ideally including both ‘wet’ science and automation/instrumentation a distinct advantage.

     

    Emotional skills and abilities

    • Advanced interpersonal skills which allow effective interaction and influence at all levels both internally and externally
    • Being able to see the big picture, whilst also having a commitment to excellence and attention to detail
    • Strong analytical skills
    • Effective negotiation capability
    • Highly intelligent and quick to learn
    • Must have ability to work in a medium-sized company environment
    • Proactive and willing to do things themselves
    • Courage and creativity to challenge the established way of doing thing

     

     

     

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