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    Regulatory Affairs Lead - London, United Kingdom - BioTalent

    BioTalent
    BioTalent London, United Kingdom

    3 weeks ago

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    Description
    Regulatory Affairs Lead – Remote – Competitive Package


    BioTalent are exclusively supporting an innovative UK based start up AI-backed software medical device company in their search for an experienced Software as a Medical Device (SaMD) Regulatory Affairs Lead.

    The company aims to effect large-scale population health improvement through the early detection and management of orthopaedic diseases.

    The company are entering an exciting time of growth and scale and require an intuitive individual to help implement the right structure to support their plans.


    The Regulatory Affairs Lead is responsible for ensuring compliance with regulatory requirements throughout the product lifecycle, from ideation, agency consultations and design file development, through to post-market surveillance.


    Responsibilities:
    nPrepare and submit regulatory documents, including 510(k) submissions, and perform regulatory filings to competent authorities (e.g. FDA).nLead in risk management activities, including the identification, assessment, and mitigation of regulatory risks associated with SaMD products.nOwn the post-market surveillance and clinical evaluation processes and activities, including adverse event reporting, complaint handling, and post-market surveillance reporting.

    Responsible for reporting to regulatory authorities where required.nSupport the maintenance and improvement of the company's quality management system (QMS) to ensure compliance with regulatory requirements, including training and audits.

    Support in 3rd party audits according to ISO 13485 and QMSR requirements.

    Skills and Qualifications:

    nBachelor's degree in degree in a relevant scientific or engineering field; advanced degree preferred (e.g., PhD, MD, or equivalent).n3+ years of experience in regulatory affairs within the medical device industry, specific SaMD experience is desirable.nStrong understanding of FDA regulations and regulatory submissions through 510k regulatory pathway.nStrong understanding for SaMD development processes according to recognised standards (e.g., IEC 62304, IEC 82304), and other international regulatory requirements.nExperience with managing Post-Market Surveillance activities for post-market surveillance reporting.

    Shortlisting for this position has begun with a view to holding interviews over the next week. For further information please contact Anita Osibuamhe at BioTalent on or respond directly to this advert.
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