Jennifer Armstrong Lyttle Email & Phone Number

Forchheim, De

Forchheim, De

Forchheim, De

IVDR (EU) 2017/746 Regulatory Affairs Team Lead.

Selected Accomplishment:- Led successful regulatory submissions for an IVD blood gas analysis test card within the US, Canada and European Union.Key Responsibilities:- Oversee preparation of preliminary application required for product clearance, involving product description, clinical trial information and sample labelling. Conduct research and gap analysis on scientific and regulatory guidelines during writing, editing, and review of submission documents. - Monitor product development lifecycle, as well as modifications to existing products, ensuring clinical trial and regulatory requirements are met for targeted geographical market to acquire approval. Enforce strict compliance with regional regulations, such as 21 CFR 820 in the US, SOR/98-282 in Canada, and 98/79/EC in the EU. - Coordinate with internal R&D and Quality Assurance departments regarding regulation changes, in order to adjust product development strategies accordingly. Review design and marketing documentation to ensure product information is factual and ISO standards are followed. - Work closely with governmental regulatory bodies and other third-party accrediting organizations on a local and international scale, such as Health Canada, FDA, CFDA and EU, throughout submission process and recalls. - Manage approvals, licenses, and authorizations for existing markets by validating accuracy of registration and device listing, and renewing and updating registration documentation within expiry deadlines. - Conduct assessments for product and labelling changes to identify potential compliance issues in geographical market. Notify appropriate governmental department or regulatory body when necessary, and initiate required amendments to documentation.

Selected Accomplishments:- Successfully acquired organic certification by applying Ministry of Agriculture standards (CAN/CGSB 32.310) in coordination with third-party accrediting bodies to align cropping operations with niche demand, ultimately tripling revenue margins of crops produced. - Facilitated regular inspections of farming operations and provided accrediting companies with required documentation to ensure compliance to organic regulations set by Ministry of Agriculture.

Broomfield, Us

Selected Accomplishments:- Managed compliance components of a project involving the development and launch of a new sleep diagnostic device, successfully acquiring clearance from the FDA, Health Canada, and EU. - Oversaw robust rebranding project, coordinating with FDA to revise and update all of the company’s records and labelling for an existing product line, while sending appropriate notifications to regulatory bodies. Key Responsibilities:- Served as project lead for hardware and software development projects, and device licensing applications, coordinating all involved departments. Monitored progress to ensure project milestones were met within set schedule, while ensuring compliance to medical regulations, quality requirements, and company policy. - Facilitated monthly meetings involving quality, design, and regulatory departments, as well as senior management, to resolve pending issues and provide sound insights regarding compliance. - Reviewed, approved, and maintained device history records, design history files, product technical files, and device master records, throughout all phases of product development. - Developed and implemented all of the company’s compliance strategies, ensuring adherence to ISO 13485 international quality management system standard, FDA Quality System Regulation 21 CFR Part 820, European Medical Device Directive 93/42/EEC, and Canadian Medical Devices Regulations SOR/98-282.- Oversaw internal audits to identify issues regarding manufacturing and design requirements, and recommend process improvements. Prepared and presented detailed audit reports for management. Coordinated external audits performed by third-party regulatory agencies to verify regulatory compliance and acquire ISO certification.

Ottawa, On, Ca

Selected Accomplishments:- Led Quality Management Systems office within Natural Resources Canada to successfully acquire ISO 9001:2000 Certification for two major NRCan labs with external registrar companies.- Sourced, prepared tender, and acquired approval for a new document control system to streamline processing of large volumes of documentation. - Spearheaded development and provided personnel training for an automated record database to effectively track HR statistical data, ensuring employee training requirements were met. Key Responsibilities:- Developed and implemented new systematic procedures from conception to approval stages. Documented and issued business processes and policies in an Operations Quality manual. - Coordinated with lab scientists, storage facilities, and purchasing department to efficiently manage and ensure compliance to quality requirements. - Served as lead auditor, managing team to execute internal audits within Operations sector, presenting audit results to top-level management and developing potential improvement strategies.

Espoo, Southern Finland, Fi

Other Roles Held: - Process Developer - Order Fulfillment/Procurement Representative- Logistics Coordinator - NPI Analyst - Repair/Customer Service Representative