VANESSA NDUNGUNA-NTEMO

Supported regulatory compliance of powered surgical instruments (class I-IIb) and accessories across global markets, ensuring alignment with ISO 13485, MDD, EU MDR, UK MDR and international regulatory requirements. Led key regulatory projects, including full technical documentation development for new FDA‑exempt surgical power tool for US market and he consolidation of intended use statements across IFUs and technical files ahead of MDR certification and EUDAMED submissions. Contributed to MDR transition activities, collaborated closely with design engineering on product compliance, prepared several technical documentations such as PMS, clinical and biological evaluation documentation, and supported global product registrations. Provided cross‑functional regulatory guidance, assisted with QMS processes including Vigilance and complaints, and ensured regulatory expectations were met throughout product lifecycle.

Responsibilities:

· Maintained and updated technical documentation for powered surgical instruments, ensuring compliance with MDD, EU MDR, UK MDR, and global regulatory requirements.

· Led drafting and compilation of technical documentation for new surgical power tool intended for US market (FDA‑exempt device).

· Led IFU alignment project to consolidate intended use statements across IFUs and technical files in preparation for MDR certification and EUDAMED submissions.

· Prepared MDR‑compliant clinical evaluation documentation in collaboration with clinical experts.

· Developed ISO 10993‑compliant Biological Evaluation Plans (BEPs) and coordinated with toxicologists on Biological Evaluation Reports (BERs) for patient-contacting devices.

· Prepared Essential Requirements/General Safety & Performance Requirements checklists for EU/UK MDR and MDSAP.

· Collaborated with design engineers to ensure regulatory compliance throughout product development, including updates to usability (OUP, formative, summative) and bench test documentation.

· Updated PMS documentation (PMSP, PMSR, SSCP, PSUR) in line with regulatory requirements.

· Reviewed and updated risk management documentation in accordance with ISO 14971 and supported hazard analysis activities.

· Interpreted and applied relevant standards and regulations to maintain QMS compliance under ISO 13485.

· Supported internal and external audits by preparing regulatory technical documentation and ensuring alignment with QMS and regulatory expectations.

· Worked with cross‑functional teams to provide regulatory guidance and drafted technical documentation ahead of SGS audits.

Supported organisation’s transition to EU MDR by reviewing product classifications, determining conformity assessment routes, assessing and rewriting technical documentation (class I-IIb), and coordinating regulatory activities across business. Contributed to MDR transition planning, UDI implementation, PMS/PMCF systems, and certificate renewal strategies. Provided cross-functional regulatory and quality support to ensure alignment with ISO 13485, EU MDR, UK MDR, and internal QMS requirements.

Responsibilities:

· Reviewed product portfolios to determine MDR classifications and conformity assessment routes.

· Conducted gap analyses of technical documentation, updated files, and revised risk management documentation in accordance with ISO 14971 and MDR requirements.

· Reviewed and updated Clinical Evaluation documents to support MDR compliance.

· Developed a structured timeline system for ongoing review and maintenance of technical documentation, including CER updates, vigilance reporting, PMS activities, and certificate renewal planning.

· Supported supply chain and economic operator compliance activities.

· Assisted with supplier ISO 13485 audits, liaised with suppliers, and supported updates to their QMS and regulatory documentation for re‑certification.

· Reviewed PMS activities performed by distributors and integrated findings into the company’s vigilance system and PMS documentation.

· Conducted internal QMS audits to ensure continuous improvement and compliance with ISO 13485, regulatory requirements, SOPs, templates, and technical documentation.

· Liaised with third parties for updates to risk documents, electrical safety reports, and other technical documentation, and led technical file update projects for Class I to IIa devices for MDR compliance.

· Acted as the primary point of contact with critical suppliers for technical file and QMS‑related queries and requirements.

Supported regulatory compliance across full lifecycle of Class I & Is medical devices, ensuring adherence to ISO 13485, UK MDR 2002, EU MDR, MDD and applicable ISO standards. Contributed to regulatory compliance for new product development and UKCA conformity projects, with strong focus on preparing MDR‑compliant Clinical Evaluation Reports and coordinating technical documentation. Provided cross‑functional regulatory guidance, supported PMS activities, contributed to clinical investigations (ISO 14155), authored SOPs, and assisted in preparing documentation for internal/external audits and continuous improvement initiatives.

Responsibilities:

• Led compliance activities for UKCA during development of Class I & Is devices.
• Prepared MDR‑compliant Clinical Evaluation Reports and drafted clinical investigation SOPs and protocols in accordance with ISO 14155 and regulatory requirements.
• Coordinated technical documentation management, including CERs, technical files, and risk management, ensuring compliance with EU MDR, ISO 13485, and ISO 14971.
• Supported PMS and PMCF activities, including data review, report writing, and customer feedback analysis.
• Guided internal teams, including Sales, Marketing, and R&D, on regulatory matters and monitored global regulatory changes to maintain compliance.
• Authored and updated QA and Regulatory SOPs to support continuous improvement and alignment with regulatory standards and internal requirements.
• Supported material safety and biological assessments in line with ISO 10993.
• Assisted with document preparation for internal and external audits (SGS).

A cross‑functional RA/QA/Clinical role that aided in regulatory compliance, strengthened QMS processes, and oversaw clinical documentation for Class IIa medical device. Acted as key regulatory contact across business, maintaining alignment with global standards and supporting successful CE marking and audit outcomes.

Responsibilities:

• Contributed to CE marking conformity assessment, supporting successful certification and market entry.
• Maintained product compliance by applying MDD 93/42/EEC and relevant ISO standards across device lifecycle.
• Updated Cinical Evaluation Report (CER) to ensure compliance with MEDDEV 2.7/1 Rev. 4, ISO 14971, ISO 14155, and relevant regulatory requirements.
• Developed and validated clinical trial protocols in accordance with ICH, GCP, and applicable regulatory frameworks, and acted as primary liaison with CRO to ensure procedural compliance.
• Optimised eQMS to streamline document control processes, including change controls, ICAs, deviations, training, and eCTD workflows, ensuring regulatory adherence.
• Organised and updated documentation for internal and external audits (BSI), facilitating successful re-certification to ISO 13485, ISO 9001, and ISO 14001.
• Supported QA Specialist in maintaining continuous compliance with ISO 13485, ISO 9001, ISO 14001, and ISO 17025 through effective QMS governance.
• Reviewed and updated regulatory and quality documentation to ensure alignment with evolving regulatory requirements and internal SOPs.
• Led review and enhancement of technical file for Class IIa medical device, ensuring strong regulatory justification and audit readiness.
• Authored and improved GCP SOPs to meet ICH, ISO 14155, and regulatory expectations.