Mavis Wryter

Diligent Regulatory Affairs professional with a law degree and 5 years’ experience in preparing, reviewing and submitting regulatory submissions, including 510Ks, MDRs, NDAs, drug product registration with FDA and coordinating and tracking regulatory-related actions. Strengths include strong analytical, communication and organizational skills.

Work History

Career Note: (March 2022 - present) Took time off for leadership and skill development

Maximus Health - Administrative and Legal Assistant

Remote September 2021 - February 2023

· Drove accountability by recording meeting minutes, preparing reports, and assessing initiative progress to allow for increased compliance with business goals.

· Enhanced compliance with company policies by reviewing industry regulations, training new hires, and utilizing legal research skills, improving staff retention rate.

· Trained new hires on company policies and compliance guidelines to ensure adherence with HIPAA rules and regulations.

· Updated spreadsheets and databases to track, analyze and report on performance.

Beach Oswald Law & Associates – Senior Paralegal

Washington, DC. April 2021 – November 2021

· Drafted and prepared various legal documents, such as visa applications, petitions, and forms required by U.S. Citizenship and Immigration Services (USCIS) or other relevant government agencies.

· Assisted in managing immigration cases from start to finish. This involved organizing case files, tracking deadlines, and ensuring that all necessary documents are submitted accurately and on time.

· Conducted legal research on immigration laws, regulations, and procedures to support attorneys in building strong cases and providing accurate advice to clients.

· Filed documents with the appropriate government agencies and maintained accurate records of all correspondence and filings related to each case.

FDAImports.com LLC – Regulatory Affairs Associate

Glen Burnie, MD October 2015 – November 2020

· Prepared and filed submissions for food and drug products such as MDR, PMA, 510K medical device with the FDA.

· Reviewed labelling and marketing information to ensure compliance and submission with the FDA.

· Coordinated and executed Compliance and regulatory initiatives and other projects.

· Worked cross-functionally to create all advertising and promotional materials.

· Identified gaps in drug product submission and executed plans to mitigate risks with management oversight.

· Negotiated and interacted with regulatory authorities during the development and review process to ensure submission approval.

· Reviewed, analyzed and reported regulatory developments affecting medical products.

· Coordinated and executed pre-approval compliance activities and the prepared, reviewed and submitted regulatory filings with the FDA.

Bennett Law Chambers – Family Law Paralegal

Mississauga, Ontario July 2013 – July 2015

· Drafted and prepared legal documents related to family law matters, such as divorce petitions, child custody agreements, prenuptial agreements, and adoption paperwork.

· Conducted legal research on relevant statutes, case law, and legal precedents to support attorneys in building strong arguments and provided accurate advice to clients.

· Completed electronic court filings at provincial and federal levels.

· Prepared and filed various documents such as Affidavits, pre-trial Conference and Settlement briefs, and Motions in preparation for trial.

· Aided in the discovery process by gathering and organizing relevant documents, drafting interrogatories and requests for production of documents, and coordinating the exchange of information between parties.

Microsoft Canada – Bilingual Paralegal

Mississauga, Ontario June 2012 – September 2014

· Provided legal assistance in Intellectual Property Litigation

· Tracked existing and new regulations and created reports on changes to laws

· Provided general administrative secretarial assistance.

· Responded to customer needs regarding Microsoft products.

· Coordinated legal document preparation and deadline tracking for various legal proceedings, ensuring timely compliance.

Mathew Fordjour Law Office – Paralegal

Mississauga Ontario January 2008 – September 2011

• Scheduled and prepared correspondence and memos as well as responded to general client needs such as problem solving.
• Drafted and filled various court applications for Divorce Proceedings, custody proceedings, child support matters.
• Facilitated client document organization from production to discovery and manage opposing party documents.
• Conducted research using designated resources to optimize efficiency. Maintain docketing updates and information flow for legal counsel.

EDUCATION

· Master of Law Degree

University of Baltimore School of Law - Baltimore MD, USA - June 2018

· Law Degree

University of Kent Law School – Canterbury Kent, UK – 2013

· Bachelor of Arts Degree– Legal Studies (Paralegal)

York University - Toronto, Canada - May 2011