Regulatory Affairs Quality Assurance
Resume:
Dear Hiring Manager
I am writing to express my strong interest in a Remote/Hybrid Regulatory Affairs Manager position within your organization. With a comprehensive background in regulatory affairs, particularly in the medical device industry, I am confident that my experience, attention to detail, and ability to navigate complex regulatory environments will make me an asset to your team.
In my current position as the Quality Assurance Regulatory Affairs Manager at Oakworks, Inc. in New Freedom, PA, I am responsible for ensuring U.S. and International Regulatory Compliance, including FDA, EU/UK, and Health Canada submissions. I lead the oversight of regulatory files, submissions, and documentation, while also coordinating internal audits and scheduling, facilitator for CAPA coordination and completion, and document control administration. Working cross-functionally and collaboratively with New Product Development and Engineering teams, I ensure that design, technical files, labeling, and user manuals comply with international regulatory requirements. I also serve as Regulatory SME for design management reviews and post-market surveillance activities.
My experience also extends beyond Oakworks, where I previously served as an International Regulatory Affairs Specialist at Carestream Health, Inc., managing product submissions, regulatory updates, and ensuring compliance across multiple international markets. I have expertise in regulatory documentation, post-market surveillance, and team leadership, and I am highly skilled in working with cross-functional teams to achieve successful outcomes.
I am excited about the opportunity to contribute my regulatory expertise, project management skills, and dedication to compliance to your organization. I look forward to the opportunity to discuss how my qualifications align with your team’s needs. Thank you for your consideration.
Sincerely,
Towanda Lorenz
*************@*****.*** 585-***-****
Towanda Lorenz
214 Orchard Ct., Red Lion, PA 17356
*************@*****.*** 585-***-****
Objective
Highly skilled and experienced Quality Assurance Regulatory Affairs professional with extensive experience in managing U.S. and international regulatory submissions, ISO internal audits, CAPA coordination, and document control. Seeking a remote or hybrid opportunity as a Regulatory Affairs Manager, Senior Regulatory Affairs Specialist, or Consultant, with a focus on medical devices. Open to relocation for the right opportunity.
Education
South University, Savannah, GA
Bachelor of Science in Legal Studies
Associate of Science in Paralegal Studies
Certifications (Completed and Anticipated)
ITIL Certification
RAC Certification (Regulatory Affairs Certification Desired)
Professional Experience
Oakworks, Inc. – New Freedom, PA
Quality Assurance Regulatory Affairs Manager
November 2023 – Present
Lead U.S. and international regulatory submissions for FDA (Class II), EU MDR, and Health Canada (Class I & Class II) regulatory compliance.
Experienced in assembling facts from various areas, analyzing data, and providing informed recommendations.
ISO 13485, ISO 14971,
KPI and Trending for complaints, CAPA, and Post Market Surveillance
ERP/QMS System/ QT-9 Administrator
Review of supporting documentation (e.g., labeling, design verification, clinical documentation, etc.)
Lead BSI Audit process for business and acted as FDA Coordinator and Scribe for short notice FDA audit.
“In the room” FDA audit experience as “Scribe” and SME
Oversee regulatory files, product updates, and approvals for international markets, including the timely submission of regulatory fees.
Collaborate with Product Development and Engineering to ensure technical files, design, and user manuals, labeling, regulatory requirements meet international standards, laws, and requirements.
Manage internal audits as Internal Audit Coordinator, ensuring timely closure of corrective actions and communication with management at all levels (President, VP of Operations, and Directors of Engineering and QARA.
Act as CAPA coordinator, overseeing CAPA Management Board meetings, tracking corrective actions, and ensuring proper documentation in QT9 ERP System.
Serve as Person Responsible for Regulatory Compliance under EU MDR Article 15, ensuring product conformity, maintaining technical documentation, and managing post-market surveillance.
Administer document control processes, ensuring correct document approvals, maintaining quality records, and facilitating compliance with ISO standards.
Key contributor to regulatory inspections and audits, providing expertise in regulatory affairs and quality assurance processes.
Apex Systems, Inc. / Zimmer Biomet
EUMDR Regulatory Affairs Consultant
January 2022 – January 2023
Led regulatory compliance initiatives, including EU MDR technical file updates and PSUR documentation creation.
Trained and mentored Regulatory Specialists, providing guidance on post-market surveillance, regulatory submissions, and EU documentation requirements.
Collaborated with cross-functional teams, including R&D and Engineering, to address regulatory inquiries and ensure compliance with international standards.
Class II, Class III, Sterile, Implantable
Carestream Health, Inc. – Rochester, NY
International Regulatory Affairs Specialist
August 2018 – December 2021
Managed regulatory submissions for FDA, Health Canada, LATAM, and EU markets, ensuring timely product registrations and compliance.
Led cross-functional teams to streamline product launch processes and address regulatory updates.
Class II medical devices
Handled post-market vigilance, CAPA, and internal/external audit activities.
Worked closely with notified bodies such as BSI, TUV, and DEKRA to ensure product compliance and timely approvals.
Skills & Expertise
Regulatory Affairs (FDA, EU MDR, Health Canada)
Internal Audits & External Audits & CAPA Management
Document Control & Quality Management Systems (QT9)
Cross-Functional Team Collaboration
Experienced with presentations and/or educational sessions
Project Management & Regulatory Submissions
Labeling review for regulatory compliance
Technical Writing (SOPs, Technical Files, Reports)
Proficient in Microsoft Office Suite, Adobe, SharePoint, Visio, Windchill, Pivot Tables, Gantt Charts, and more.
Volunteer Activities
York Regional Area Citizen Police Academy (Cadet)
Helping Hands Men's Shelter (Server), Baltimore, MD
Open Door Mission Women and Children’s Shelter (Donor), Rochester, NY
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