Nicole Birch Email & Phone Number

Thousand Oaks, Ca, Us

Minneapolis, Mn, Us

- Managed a team of 6 regulatory affairs specialists to execute an aggressive submission strategy for the US and EU over 6 months, leading to an expedited approval that saved the company over $300,000 in submission cost.- Managed the regulatory strategy for 12 devices (hardware, software, and mobile applications) and secured the regulatory approval in the US and EU. - Developed and implemented effective regulatory strategies for short-term and long-term medical device changes by collaborating with cross-functional stakeholders.- Lead in executing regulatory activities for the product development team, including authoring regulatory submissions, interacting and negotiating with regulatory agencies, reviewing test documents, and assessing changes, for class I, II, and Ill devices.- Authored PMA supplements; panel track, breakthrough device designation, annual report, master file, change being effected, pre-submission, and real time review for new products and product changes.- Maintain current knowledge of the developments and changes to applicable regulations and industry standards and initiate actions to assure compliance to these regulations.

Santa Clarita, Ca, Us

- Implemented and managed the process for the FDA Unique Device Identifier (UDI) and ensured accuracy and comprehensiveness of product data for submission to Global Unique Device Identification Database (GUDID).- Prepared international regulatory submissions for new products and product license renewals, and supported the maintenance of Technical Dossier, Declaration of Conformity, and Certificates to Foreign Government.- Completed the Health Canada Annual License Renewal for the company’s manufacturing facilities and active product licenses.- Submitted the FDA Annual Report for a Class III medical device to maintain premarket approvals.- Implemented procedures to maintain regulatory required country standards and international standards, which ensured that product development teams could comply with regulatory requirements.- Developed a labeling validation process to assure compliance with European Medical Devices Regulation (MDR) and 21 CFR 803.- Provided regulatory support during internal, TUV, FDA, MFDS, and ANVISA quality system audits.- Devised regulatory strategies and advised project teams on regulatory requirements and implemented data accuracy checks during product phase closures to ensure regulatory compliance.- Reviewed changes in manufacturing processes and labeling during engineering change order processes.-Managed employee training for all new recruits over a 6 month period and offered continuous advice, guidance, and mentorship on duties and best practices.

Santa Clarita, Ca, Us

- Developed an electronic reporting system in Salesforce to remain compliant with the FDA electronic medical device reporting requirements. Improved adverse event reporting processes by establishing a global eMDR system, which aligned data formatting to FDA electronic adverse event reporting requirements, gave ease of access to the global complaint handling team, and saved approximately $60,000 in labor costs annually.- Participated in the safety review board and identified potential safety hazards.- Served as subject matter expert adverse event reporting during quality system audit. - Assembled adverse event data to support China and India tender bids.- Improved the quality system by initiating corrective and preventive actions.- Responded to information requests by regulatory authorities related to adverse event reports.- Managed complaint files for adverse event reports and vigilance reports.