Janice Thompson Email & Phone Number

* Manage a small team to plan and execute regulatory activities to obtain and maintain regulatory approvals in accordance with project timelines.* Provide independent regulatory guidance to business partners and cross functional project teams, communicate regulatory environment and product submission requirements.* Manage and assist with preparation of pre-market applications to US and EU regulatory agencies, acting as regulatory representative with regulatory agencies as appropriate.* Partner with the Regulatory Operations team to facilitate the preparation and submission of Rest of World registration dossiers for new and modified software devices.* Provide Regulatory Affairs support during internal and external audits.* Assess product and manufacturing changes for compliance with applicable standards and regulations.

* Provide regulatory planning and strategy to device development teams and internal stakeholders for compliance with international standards, such as ISO, IEC, and global medical device regulations.* Author and prepare regulatory submissions including, but not limited to, EU MDR Technical Documentation, PMA Annual Reports, Canadian change notifications, US FDA 510(k).* Assess product and manufacturing changes for compliance with applicable standards and regulations.* Review and approval of advertising and promotional materials.* Create SAMD Design Controls process.

Kansas City, Missouri Area

• Author and prepare 510(k) submissions, risk management reports, and technical files• Assess product and manufacturing changes for compliance with applicable standards and regulations• Provide regulatory input and oversight for product design and development, including review of specifications, protocols and reports, change control, product complaints, and vigilance reporting• Provide regulatory planning and strategy to device development teams and internal stakeholders for compliance with international standards, such as ISO, IEC, and medical device regulations• Evaluation of new solutions and solution enhancements for device applicability

Kansas City, Missouri Area

Kansas City, Missouri Area