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Jessica Addison, BSc

Principal Medical Writer, Regulatory

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Jessica earned a degree in Genetics from the University of Newcastle before joining medical device consultancy, Emergo, in 2014 where she gained Clinical Evaluation Report (CER) writing experience for a range of device types and covering Class I-III and animal tissue. While at Emergo, Jessica worked on EU and U.S. regulatory submissions for a wide range of device types and classifications under a variety of manufacturing arrangements. Jessica joined NAMSA in 2018 where she focuses on high-risk and novel devices, providing regulatory, clinical evaluation, medical writing and Post-Market Clinical Follow-Up (PMCF) strategies.

CORE COMPETENCIES

  • Clinical Evaluation Report (CER) writing to MDR and MEDDEV 2.7/1 Rev 4: complete compilation, upgrades and updates, covering a variety of strategies such as non-clinical routes per MDR article 61 section 10
  • Development of regulatory and clinical evaluation strategies for MDR transition, considering existing strategy and available data integration of Post-Market Surveillance (PMS) and PMCF activities
  • Creation and review of PMS/PMCF documentation, per MDCG 2020-7, as well as assisting with the development of high quality surveys
  • Creation and review of SSCP and CDP, per MDCG 2019-9, including patient part/lay person translation
  • Serves as technical lead/reviewer on complex multi-CER projects
  • Assessing CER grouping for MDD 93/42/EEC and MDR 2017/745 classification assessments
  • High knowledge of EU regulatory requirements, including Gap Analyses of Technical Documentation to MDR 2017/745 requirements
  • Deep understanding of EU regulatory Technical Documentation and compilation for a range of device types and risk classifications
  • Contribution to animal tissue justifications
  • Regulatory road-mapping for a wide range of device types and risk classifications in multiple global markets
  • Regulatory impact assessments of manufacturing footprint and legal entity changes on existing regulatory approvals
  • Supplier assessments and approvals under various manufacturing arrangements
  • Experience with multiple global market regulatory requirements

RECENT PROJECTS 

  • Regulatory, clinical evaluation and PMCF strategies for transition to MDR
  • MDR remediation project to address non-conformance within clinical evaluation, PMS/PMCF and SSCP
  • Notified Body non-conformance response project