Patricia L. Wightman
Orange,CA
Summary
Experienced with regulatory compliance, documentation, and submissions. Utilizes comprehensive knowledge of regulatory landscapes to streamline approval processes. Strong understanding of industry regulations and collaborative project management.
Overview
12
12
years of professional experience
Work History
Regulatory Affairs, Specialist II
Alcon
11.2024 - 05.2025
- Prepared regulatory documents for Health Canada submissions for class II/III products.
- Prepared regulatory submissions for domestic or international projects.
- Determined types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Prepared additional information or responses as requested by regulatory agencies and regional regulatory partners.
- Prepared and maintain technical files as necessary to obtain and sustain product approval.
- Prepared responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Developed and maintained comprehensive documentation for regulatory submissions, enhancing accuracy and consistency.
- Prepared and submitted regulatory file applications and supporting documentation.
- Received, researched and resolved consumer inquiries.
- Established strong relationships with global regulatory counterparts, facilitating efficient information exchange and collaboration.
Regulatory Affairs, Project Manager
MicroVention, Inc.
06.2023 - 05.2024
- Executed, planned, and developed Global Strategies to implement Corporate Address Change and Manufacturing Site Transfers for Global Regional implementations.
- Mentored 1:1 with junior staff members on department processes, procedural improvements, and compliance with International regulations.
- Built team cohesiveness by influencing and supporting team members with daily challenges and strategizing effective solutions.
- Promoted to 3 positions
Senior Specialist, Regulatory Affairs
MicroVention, Inc.
08.2019 - 06.2023
- Represented International Regulatory Affairs during new product development meetings to facilitate successful approvals and ensure regional and local guidelines were in compliance.
- Worked with cross-functional teams to implement product design changes and determine regulatory impact on current product approvals, while determining if distribution notification were required for implementation.
- Submissions for new products and renewal registrations in EMEA, LATAM, APAC regions.
- Responded to Health Authority questions for clarifications of supporting documentation, to gain registration approvals.
- Regulatory lead for Global GMP facility audits and approvals for Brazil, Korea, Taiwan.
Regulatory Affairs, Regulatory Affairs Specialist
Johnson & Johnson Surgical Vision, Inc. (JJSV)
06.2018 - 08.2019
- Supported business needs of surgical vision and consumer eye health products to complete submissions and registrations (APAC, EMEA, LATAM);
- Compiled regulatory activities from regional project managers and directors to be presented to senior management;
- Supported Medical Device Regulations (MDR) while phasing out procedures related to Medical Device Directive in effort to avoid challenges to registration and submissions timelines;
- Trained and mentored new colleagues to use Request Manager and TeamCenter;
- Compiled and interpret data from post-market surveillance to support product registrations;
- Prepared regulatory documents required for OUS submissions, such as Certificate of Foreign Governments (CFGs), ISO certificates, CE certificates, and Manufacturing Change Orders for regulatory-related standard operating procedures.
- Developed and maintained regulatory documentation for product approvals and renewals.
- Collaborated with cross-functional teams to address compliance issues and streamline processes.
Project Specialist, Regulatory Affairs
Masimo Corporation
03.2016 - 03.2018
- Supported US 510(k) filings;
- Assessed product design changes;
- Conducted internal audits;
- Maintained RA databases and dashboards to monitor active global registrations and approvals for regulations and standards;
- Reviewed and approved design and production test protocols;
- Retrieved FDA FOIA records;
- Developed regulatory process map/flow charts to implement design changes;
- Trained RA and Engineering teams on: promotional labeling, master data, GUDID, UNIMED;
- Train new members.
Quality Compliance Specialist, Quality Compliance
Masimo Corporation
09.2015 - 03.2016
- Performed investigational reviews of incoming customer complaints to ensure compliance;
- Supported customers for supporting documentation for product investigation phase during failure analysis;
- Collaborated with team for correct course of action to address issues;
- Ensured timely communications to management.
- Effectively supported the Compliance Department in completion of investigations for timely complaint closure;
- Participated in process mapping to implement important process improvements.
Technical Writer, R&D Engineering
BIOSENSE WEBSTER
07.2014 - 11.2014
- Gathered, composed, and edited technical information into clear, concise, readable documents, flow charts, photos, and graphics;
- Observed and interviewed research and manufacturing personnel;
- Created documentation to describe step-by-step instructions to be used by manufacturing personnel;
- Photographed and composed diagrams to further illustrate essential steps of the assembly process for publication of Work Instructions documentation.
Senior Quality Reviewer/Specialist, Quality Assurance
AVRIO BIOPHARMACEUTICALS
07.2013 - 04.2014
- Supported Quality Assurance Department including; data review, respond to observations, manage system, and manage the transfer of documents from a paper based system into electronic system, and manage Biopharmaceuticals (a subsidiary of Irvine Pharmaceutical Services) under tight deadlines to ensure compliance;
- Reviewed reports to verify compliance to methods, procedures, and product specifications in a cGMP environment with zero error expectations;
- Worked to address Client Audit observations (perceived gaps in laboratory safety, regulatory compliance, and quality);
- Improved the improvement and efficiency of the electronic documentation control system by processing over 300 Change Requests (CR), Document Obsolete Request (DOR), Report Requests (RR), Special Training Requests (QIR), and Corrective Action and Preventative Action (CAPA), in QMS.
- Major accomplishments: Successfully prepared and transferred over 300 documents to electronic system; Trained personnel to perform document collaboration functions in support of SOP and Form migration.
Education
Bachelor of Science - Chemistry/Biology
Chapman University
Orange, CASkills
- Advanced Microsoft Office Suite
- WindChill PLM / Veeva RIM Platform / Rimsys RIM Platform
- ETQ / Agile PLM / Expandable ERP
- Team Center / Request Manager
- SharePoint / Oracle LIMS / Trackwise
- Excellent communications / Proficient technical writer
- Self-driven / Highly motivated / Positive team player
- Strategic mindset / Organized / Very ambitious
- Detail-directed project management
Timeline
Regulatory Affairs, Specialist II
Alcon
11.2024 - 05.2025
Regulatory Affairs, Project Manager
MicroVention, Inc.
06.2023 - 05.2024
Senior Specialist, Regulatory Affairs
MicroVention, Inc.
08.2019 - 06.2023
Regulatory Affairs, Regulatory Affairs Specialist
Johnson & Johnson Surgical Vision, Inc. (JJSV)
06.2018 - 08.2019
Project Specialist, Regulatory Affairs
Masimo Corporation
03.2016 - 03.2018
Quality Compliance Specialist, Quality Compliance
Masimo Corporation
09.2015 - 03.2016
Technical Writer, R&D Engineering
BIOSENSE WEBSTER
07.2014 - 11.2014
Senior Quality Reviewer/Specialist, Quality Assurance
AVRIO BIOPHARMACEUTICALS
07.2013 - 04.2014
Bachelor of Science - Chemistry/Biology
Chapman University
Similar Profiles
Erika J. JacobsErika J. Jacobs
TS Maintenance and Calibration Lead at AlconTS Maintenance and Calibration Lead at Alcon
Cliff GenattCliff Genatt
Regional Service Manager – Southeast at ALCONRegional Service Manager – Southeast at ALCON
Mercades JimenezMercades Jimenez
Machine Operator Technician at AlconMachine Operator Technician at Alcon
Stephanie RiveraStephanie Rivera
Family Nurse Practitioner at Caduceus Medical GroupFamily Nurse Practitioner at Caduceus Medical Group
Ella ChangElla Chang
Freshman and Sophomore Class President at Villa Park High SchoolFreshman and Sophomore Class President at Villa Park High School