Experience

Sword Health

• United States
• Wellness and Fitness Services
• 500 - 600 Employee

• Senior Quality & Regulatory Officer

  • Jun 2022 - Present

  • Consultant role within a unicorn start-up digital tech company. Lead the regulatory activities, including developing regulatory strategies, regulatory intelligence and PMS for new and existing products. • Provide regulatory guidance and support to project teams and internal customers to support new product development and existing products to align with regulatory requirements. • Key contributor and collaborator towards the development, implementation and adherence of the Quality Management System (QMS) for the design and development of medical devices. • Responsible for co-ordination and liaison within a cross-functional team to implement the QMS and complete EU & UK MDR technical files for a Class IIa & Class I product within a 6-month timeframe. • Oversee regulatory activities related to the Notified Body technical and clinical rounds of questions and interface for consultants during Biocompatibility, Clinical Evaluation and 60601 compliance work. • Main point of contact for the training and awareness of QARA throughout the company, through the interpretation of specific requirements regarding product standards and guidance documents. • Mentor to junior members of the team and prepared members of staff new to medical device audits to be confident to participate within internal and third-party audits. • Initiated and implemented the customer complaint and vigilance process and the supplier onboarding approval process. • Nominated member of the Notion council for the QARA department. Show less



Sensyne Health

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Senior Quality & Regulatory Officer

  • Jun 2021 - Jun 2022

  • Compile MDR Technical Files for Class IIa and IIb software as medical device products and coordinate responses for notified body technical and clinical rounds of questions.• Creation and maintenance of MDD, IVDD CE and UKCA technical files and applications for derogation for SaMD products. Liaise with Clients, Notified Bodies and Health Authorities. • Regulatory knowledge of devices in various territories including USA, Canada and Australia. • Conduct QARA activities including customer complaints, vigilance reporting, NCR, CAPA, Supplier Assessments throughout the company, Business Continuity Planning and Management Review Meetings.• Create, maintain and update QMS documentation and responsible for the training matrix of all Sensyne Health employees. Review of marketing claims and materials prior to public release.• Actively participate in internal and external audits, preparation of CAP reports from external audits.• Consulted three Lab10x projects (digital health ideas from the University of Oxford) for the creation of a Quality Management System and product Technical File (MD & IVD). • Assist in maternity cover for Information Governance activities, including Data Breach Reporting, Data Process Protocol, Data Protection Impact Assessment, Cookie Policy, Terms of Use and Privacy Policy.• Perform induction for Regulatory, Quality, Risk and Information Governance to new Sensyne Health staff.• Creation of slides for investors, training, webinars for Quality & Regulatory activities and awareness.• Collaborated with the clinical risk team to deliver an IT Healthcare solution for deployment into NHS organisations and maintain the company-wide risk management process in compliance with ISO14971 and DCB0129 with the use of a ticketing system. Show less

• Quality and Regulatory Affairs Associate

  • Jan 2020 - Jun 2021



The Binding Site

• United Kingdom
• Medical Equipment Manufacturing
• 700 & Above Employee

• Regulatory Affairs Officer

  • Feb 2018 - Dec 2019

  • Compile and organise laboratory testing results and marketing material for in-vitro diagnostic assays into regulatory document packages required for submissions and annual registrations. Prepare and submit document packages to global regulatory agencies and external audits, including FDA 510(k) submission, STED and CSDT (Malaysia).• Coordinate monthly reports on worldwide dossiers to company directors and managers, which include risk assessment, mitigation and timelines for registration approval. • Manage vigilance compliance and reporting Field Safety Notices to worldwide competent authorities. Write product recall reports and corrective actions used internally and by competent authorities. Ensure vigilance documentation is maintained to the highest standard for internal and external audits (including MDSAP).• Qualified external Vigilance and Post Market Surveillance professional for Medical Device and In Vitro Diagnostic products. Delegate at MedTech Forum Paris 2019.• Studying for Regulatory Affairs Certification (RAC). • Interviewed and selected as Mental Health Care support officer for the company. Show less

• Technical Specialist

  • Apr 2017 - Feb 2018

  • Responsible for addressing customer technical and non-technical complaints and enquiries for all Binding Site products, ranging from analysers, including software and in vitro diagnostic assays.• Coordinated decision-making processes across various departments within the company to troubleshoot and promptly resolve customer issues to the highest quality.• Wrote technical quality reports on internal analytical procedures and processes to resolve product complaints and queries from international customers, subsidiaries and product distributors.• Arranged product supply solutions for global customer, distributors and subsidiaries through teleconference, telephonic and email communication.• Performed risk assessments and coordinated risk meetings to discuss product complaint cases and ensure the appropriate mitigative action is in place prior to case closure. Show less



Vitalograph

• Ireland
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Clinical Trial Project Assistant

  • Sep 2015 - Mar 2017

  • Provided face-to-face and remote medical device training to international health-care professionals, including at investigator meetings in Warsaw (Feb 2016) and Madrid (2016). • Advised health-care professionals on clinical study procedures and regulations. • Led report monitoring, competency assessments, control and traceability of Data Corrections for the study Sponsor, health-care professionals and medical monitors for clinical trial sites. • Trained new colleagues on clinical trial data report monitoring and the organisation of clinical study documentation to GCP standards and guidelines. • Organised Quality Checks on various documents in multiple languages and User Acceptance Testing on medical device equipment and software. • Secured new company benefits for all colleagues in the form of a corporate discount for a membership at a local health centre. Show less

• Laboratory Assistant

  • Jul 2013 - Aug 2014

  • Worked within the Antisera Production department, ran affinity chromatography and performed antisera concentrations to specific values and ranges. • Performed quality control techniques used to check contamination, including 4mg plates, immunoelectrophoresis and immunodiffusion. • Worked individually and as part of a team to ensure production was running efficiently and at full capacity. • Nominated twice to represent placement students within the company and support, advise and provide tours for students undergoing interviews and assessments for a role within the company. Show less



Hilton Hotel

• United States
• Hospitality

• Food and Beverage Assistant

  • Oct 2011 - Oct 2013

  • Working within the conference and events, restaurant and hosting sectors. • Received customer recognition for providing good service. • Taking telephone enquiries within specified time frame in a friendly and professional manner. • Working within the conference and events, restaurant and hosting sectors. • Received customer recognition for providing good service. • Taking telephone enquiries within specified time frame in a friendly and professional manner.