Towanda D. Lorenz

** ************ ****, *******, *** York 14580

adym0q@r.postjobfree.com, 585-****-**** Mobile

Objective:

Seeking a career opportunity to benefit the business through mission focused support as a International Regulatory Specialist or Regulatory Affairs Manager. NY State Notary Commissioned, organized, results-oriented regulatory professional with 4 years’ experience utilizing skills in US, Latin America and, Health Canada product registrations for product classes I, II, and III, EUMDR Technical File remediation for Class I, II, III, Ir, Is, and implantables with regard to EUDAMED implementation, database management, documentation digital, oral and written communications.

Education:

South University Savannah Georgia Associate Science Paralegal Studies

Bachelor Science Legal Studies (Pending Graduation)

US Army- Honorable Discharge

Experience:

Apex Systems /Zimmer Biomet Aug 2021 – Present

EUMDR Regulatory Affairs Consultant

Utilizing practical skills in project management.

Updating, creating and drafting PSUR, GPSR, and technical documentation.

Assist with assembly, distribution, storage and tracking, and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish regulatory submissions (electronic and paper format).

Respond to requests from foreign governments and/or distributors as needed

Assist with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products

Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products

Evaluate the risk of proposed regulatory strategies; may offer solutions

Reviews proposed labelling for compliance with applicable global regulations

Writes and manages the development of package inserts

Reviews and evaluations of promotion and advertising material for compliance with applicable regulations

Reviews proposed product changes for impact on the regulatory status of the product

Communicates with regulatory and governmental agencies with supervision

Applies FDA regulations to business practices and provides regulatory input, advice, and guidance to design teams.

Strong writing, communication, and interpersonal skills.

Strong attention to detail; ability to multi-task and balance competing priorities.

Knowledge of the overall business environment, the orthopedic industry, and the marketplace

Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs, and combination products as needed, based on functional area

Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels.

Knowledge of FDA, EU, and other major regulatory body regulations.

Ability to identify risk and assess impact in Regulatory strategies

Strong problem solving and analytical skills

Effective negotiating and influencing skills

Basic computer skills, including Microsoft Office Suite

Carestream Health, Inc. Aug 2018 – Dec 2021

International Regulatory Affairs Specialist

Communicated at all levels within the organization to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs.

Advised project teams and managers on subjects such as premarket regulatory requirements, and labelling requirements for Health Canada product submissions.

510(K) and technical file (began training before departure), ISO13485 regulatory guidelines, EUMDR with regard to EUDAMED implementation, Health Canada submissions, Latin America Region, and US, FDA Establishment and Device listings, FDA Annual updates and reporting, Post Market Vigilance and Reporting, SOP’s, and CAPA experiences.

Maintained product FDA registration and device listings and annual establishment renewals.

Implemented new procedures to streamline the product launch and modification process which resulted in faster Health Canada product launches by 20% and increase overall compliance. Also, trained the project teams and regulatory managers on this process.

Regulatory liaison/representative in internal or external audits

Maintained current knowledge base of existing and emerging regulations, standards, and guidance documents. Identified relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings.

Provided input and regulatory updates as the RA Representative for Canada’s Annual Management Review meetings.

Acted as the key team member in helping facilitate documentation transfer activities to support company transition to several markets and managed priorities despite challenges posed by the COVID-19.

Determined the types of regulatory submissions and/or internal documentation that are required in situations such as proposed device changes or labeling changes.

Performed as subject matter expect on Health Canada medical device licenses and product registration activities. Also, required to explain, translate, and interpret Health Canada regulatory guidelines, policies, or procedures to team members and senior management.

Conducted and participated in CAPA activities aimed to reduce process errors by updating and revamping SOP’s.

Performed regulatory impact assessments for manufacturing and product changes for notification to regulatory agencies.

Lead cross-functional and multi-national teams as project manager to drive commercial availability for several products’ succession of software upgrades.

Carestream Health, Inc.–Datrose Jan 2018 – Aug 2018

International Regulatory Affairs Specialist

Responsible for maintaining regulatory compliance by interpreting and evaluating federal and state registration requirements; and updating regulatory database tracking systems for products.

Preparing and supporting worldwide submissions for new products and handling product modification and change requests as required ensuring timely approval for market release.

Responsibilities include reviewing significant regulatory issues with PLM’s, Project Teams, and Director as necessary and negotiating submission issues directly with foreign gov’t agencies personnel.

Plan, coordinate and prepare document packages for regulatory submissions, including Class I, Class II and III

U.S. FDA and Health Canada. Trained on PMA and (510(k) and Tech Files.

MS Office Suite 2007-2010 Pro, MS Office 365, IBM Notes Social Edition, Cisco VoIP telephone systems, HP Elite Book Laptop, Master Control for QMS and SOP’s, Visio, and SharePoint.

Savin Engineers, Inc. May 2017 – Jan 2018

Administrative Assistant

Administrative/receptionist duties, greeting visitors, conference, and meeting set-up.

Administrative support and mail distribution for 8 project managers and two separate division offices.

MS Office Suite 2010 Pro, Smart Board, Touch Screen, and Display technology operation.

Conference call, meeting minutes, and event planning and meeting preparation skills utilized.

Global Resource Solutions Corporation Oct 2016 – May 2017

Sensitive Information Security Escort (On call)

Greeting visitors and making security rounds

Alarm/building security management

Protecting the integrity of personal Identifiable information

Supervision of construction work groups and handling documentation responsibilities

Lay off/Unemployment Mar 2015 – Oct 2016

Camber Corporation Aug 2013 – Mar 2015

Mission Support Specialist

MS Office Suite 2010 Pro, Adobe Acrobat 8 & 9

Telephone management, Calendaring, meetings, visitors, security

PKI initial setup

Records Management

Daily, weekly, monthly reporting

Fax, copier, printer usage

Data Tracking

Office management and subordinate supervision (one lower-level admin)

Scientific Research Corporation Nov 2010 – Nov 2012

Senior Administrative Assistant

MS Office Suite Pro, Adobe Acrobat 8, Blackboard, Whiteboard, MS Office 360, Chandelier training records database

SharePoint 2010 Pro; MS Office 360

ATAAPS, JPAS, Poly Com, VTC Operations

PKI Initial Setup assistance

Calendar management, routine reporting, handling all visitors, website content management, distribution lists, office supply management, and conferences and meetings, and travel arrangements.

Database, Power Point Slide presentation, and spreadsheet creation

Federal Trade Commission Oct 2009 – Oct 2010

Honors Paralegal Specialist

Utilized computer skills with MS Office Suite 2007 Pro, Concordance, Lexis Nexis, Westlaw, Summation

Prepared declarations and affidavits, interview public participants and witnesses, document tracking

Performed Chart, slide, and electronic evidence material preparations.

Courtroom Observation, legal research, and writing, briefing pending cases.

Assisted one main attorney and supported 3 other attorneys when required.

York County District Attorney Office York PA Summer 2008

Paralegal Intern (Degree Externship Experience)

Briefed Cases

Participated in attorney assisted courtroom observation activities.

Handled case evidence preparations.

Telephone management (incoming/outgoing)

Prepared declarations and interrogatories received from witnesses and clients.

Fax, printer, copier, laptop, projector, whiteboard

Attorney litigation courtroom assistance

Volunteer Activities

York Regional Area Citizen Police Academy (Cadet) York, PA

Memorial Hospital (Labor and Delivery) York, PA

Helping Hands Men's Shelter (Server) Baltimore, MD

Open Door Mission Women and Children’s Shelter (Time and Product Donation) Rochester, NY

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