Linda began her career as a Regulatory Affairs Specialist at a global Contract Research Organization (CRO) before moving to the medical device industry. Linda has over 10 years’ experience working for small and medium size medical device companies that manufacture a range of medical devices, including active devices and implants. Her previous roles included the generation and maintenance of technical documentation and establishing medical device registrations in the EU and global markets.

CORE COMPETENCIES

• Authoring Clinical Evaluation Reports (CER), ensuring compliance to the Medical Device Regulation (MDR) and Medical Device Coordination Group (MDCG) guidance documents for Class I-III devices, including products using animal tissue
• Utilizing a wide range of regulatory strategies, such as equivalence demonstration, well-established technology and non-clinical routes
• Project management of clinical trials and Post-Market Clinical Follow-Up (PMCF) studies to build data and supporting evidence for CE-marking under MDR
• Assisting Clients with EU regulatory requirements, MDD compliance and Gap Analysis in preparation for MDR
• Compiling EU regulatory technical documentation for CE-marking
• Preparing and submitting registration documents in a range of global markets
• Regulatory project management, including programs for novel devices and virtual-manufactured products
• Generating and maintaining medical device labelling, including IFU, according to MDD and harmonized standards
• Managing Post-Market Surveillance (PMS), including PMCF studies and vigilance activities
• Providing technical leadership and organizational skills for managing multi-CER projects

RECENT PROJECTS

• Helped conduct a Notified Body audit non-conformance project, including a CER on a well-established technology device
• Successful management of multi-CER project, ensuring consistency among deliverables, high-quality review and on-time delivery, including expedited projects
• Authoring Summary of Safety and Clinical Performance (SSCPs) to the requirements of MDCG 2019-9