FAULKNER ZENNAH, MBA Quality & Regulatory Affairs professional

Coon Rapids, MN 55433 Tel:651-***-**** Email: ad3iab@r.postjobfree.com.

Regulatory Affairs Quality and Compliance Regulatory Strategy

QUALIFICATION SUMMARY

Purposeful, self-motivated, dynamic, and versatile professional with more than 18 years of combined experience in quality and regulatory compliance in project leadership, medical devices, and technical documentation. Strong research and analytical skills with demonstrated adeptness in information gathering, meticulousness, and resourcefulness in task execution, and completion. Equipped with a strong scientific and technical background and well-versed in U.S FDA Regulation, EU MDD and MDR 2017/745, and other international medical device, drugs, and biologics regulations. Effective leader, accustomed to building, mentoring, and motivating high-performing technical teams.

KEY SKILLS AND REGULATORY AFFAIRS KNOWLEDGE

Leadership

Adaptability and Multitasking

Communication

Healthcare Laws

Technical Documentation

Planning/budgeting

Collaboration

Legal systems

Project mgmt.

Research

Relationship building

Data Analysis

RELEVANT PROFESSIONAL EXPERIENCE

Regulatory Affairs Specialist Sept. 2022- Sep. 2023

Bracco Medical Technologies Eden Prairie, MN

Provided regulatory support to meet compliance with current and evolving worldwide regulatory submission requirements for regions including, but not limited to the United States, Canada, Japan, China, South Korea, and Australia/New Zealand. Advise regulatory submission teams on such requirements.

Reviewed and updated Periodic Safety Update Report (PSUR), EU MDR technical documents, technical files, Declaration of Conformity (DoC), Post Market Surveillance Report, and Essential Requirement Checklist (ERC) or General Safety and Performance Report (GSPR).

Performed regulatory assessment and approval for all engineering design changes to support the rationale for change and ensure compliance with EU MDR, FDA, Health Canada, South Korea, and other impacted geographies.

Improved international submission processes by creating a regulatory impact inquiry process map, streamlining submissions, and reducing submission times by 30%.

Facilitated regulatory research, publishing reports on regulatory intelligence, aligning with the need to maintain proficiency in worldwide regulatory requirements.

Monitored proposed and current global regulations and guidance; assessed the impact of such regulations and guidance on assigned project(s), proposing suggestions on utilizing regulatory updates to expedite the approval process.

Approved engineering design changes, ensuring adherence to ISO 13485 and EU MDD/MDR 2017/745.

Supported U.S. and EU regulatory filings for new and modified products.

Represented the Regulatory Affairs Team on cross-functional projects that included product development, manufacturing process changes, quality, and continuous improvement efforts.

Represented Bracco as a liaison with regulatory authorities, fostering positive relationships through effective oral and written communication. Prepared and submitted regulatory documentation and applications, ensuring accuracy and compliance with regulatory requirements.

Compliance/Audit Specialist MDR/Vigilance Nov 2012 – Sept 2022

Neuromodulation, Medtronic Corporation Fridley, MN

Evaluated and documented comments and complaints on all Neuromodulation products per regulatory standards, applying policies and procedures, and interacting with patients, medical professionals, and sales representatives in obtaining critical information to ensure compliance with quality system regulations and FDA and TUV investigation.

Evaluated incoming product events to decide MDR and Vigilance reporting eligibility in compliance with post-market and adverse event reporting requirements.

Generated complete regulatory reports for prompt submission to the FDA and other regulatory agencies, ensuring a 100% on-time submission rate and avoiding potential fines or regulatory issues while coordinating follow-up audit activities in conducting internal and regulatory agency audits, and inspections.

Initiated and managed quality monitoring programs that reduced manufacturing site ID errors leading to a 95% reduction in errors related to manufacturing site ID compliance.

Collaborated with Regulatory Affairs leadership to implement corrective actions, resulting in an 80% reduction in compliance shortfalls and ensuring the continued market presence of Neuromodulation products.

Chemical Technician/Team Lead Sept. 2002 – Nov. 2012

MECC, Medtronic Corporation Brooklyn Center, MN

Successfully developed and executed processes and led efforts that increased chemical production yield of Amino Oleic Acid Synthesis by 40%, resulting in substantial cost savings and increased availability of this critical compound.

Served as Team Lead in synthesizing a high-purity organic compound called Amino Oleic Acid (AOA) used to treat tissue valves to prevent calcification,

Prepared medical adhesive solution, DADET hardener, epoxy kits, and polyurethane adhesive solution for Monolithic Controlled Released Devices (MCRD).

Formulated a foaming electrolyte for development consumption and partnered with engineers to set up reactor facilities in Mexico for production operations. This enabled the company to expand its manufacturing capabilities and market reach into Mexico.

EDUCATION

MS, Master of Science in Regulatory Affairs for Drugs, Biologics, & Medical Devices

Northeastern University • Boston, MA

MBA, Master of Business Administration, University of Illinois • Urbana-Champaign

MHA, Master of Healthcare Administration, Des Moines University College of Medicine and Health Sciences

B.S. in Chemistry, University of Minnesota • Minneapolis, MN

Professional Affiliations: Regulatory Affairs Professional Society (RAPS), and American Society of Quality (ASQ).

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