Regulatory Affairs Manager

• May 2021 - Present

Associate Manager, Regulatory Affairs

• Jul 2020 - Mar 2021

Senior Regulatory Affairs Specialist

• Aug 2019 - Jul 2020

Regulatory Affairs Specialist

• Sep 2018 - Aug 2019

- Regulatory lead for three product development projects in spinal implants and surgical instruments. Reviewing DHF documentation from Phase I-IV, providing input on US, EU and other relevant markets’ regulations (requirements, testing standards) and strategy in submission and timelines.- Comprehensive review and update of three Technical File/STEDs for Class I, IIa/IIb spinal fixation medical devices. Review of Clinical Evaluation Report (CER) and Risk Management Plan updates for same product lines. - Created new process (SOP and Forms) to assess the Impact of Design Changes in OUS markets. Created Post-Approval Checklist to communicate and release product globally. Reviewed and updated Technical File/STED template. - Responsible for LATAM submissions, from strategy, management of licenses, renewals, responding to deficiency letters, to preparing technical documents, working closely with commercial and marketing teams to achieve aggressive timelines. - Review and approval of global promotional materials of designated product lines and all material specific to LATAM. Show less

Regulatory Affairs Strategist, International

• Feb 2017 - Jul 2018

• Prepare regulatory submissions of a portfolio of more than 50 medical devices Class I, II, and III: electromechanical contrast media injectors, sterile and non-sterile disposables and software for Mexico, Central America/Caribbean and South America (LATAM) countries. • Responsible for responding to government agencies on requests for additional information and/or clarifications on submitted dossiers, renewals or amendments (RAIs).• Responsible for labeling and packaging compliance of medical devices with LATAM countries’ local regulation. • Assess the impact of product design changes to current licenses, submitting amendments/notifications to regulatory agencies when necessary.• Monitor changes and new regulation in LATAM countries, assessing impact to current projects and launch plans.• Assess changes in FDA or EU MDD/MDR regulation that may impact registration in LATAM countries. • Represent the Regulatory team in cross functional project teams when launching new/legacy products in supporting, developing and implementing regulatory strategies.• Manage relationship with distributors, OEMs and affiliates who hold Bayer licenses and/or regulatory responsibilities.• Assist in the preparation of documents regarding CAPAs, recalls and notifications as needed.• Create reports/presentations to senior management and project/product leads on registration status, strategies, challenges, new regulations, etc. Show less

Senior Legal and Compliance Specialist

• Aug 2013 - Feb 2017

• Draft and negotiate services agreements, requests for proposal, consulting, speaker agreements, CDAs, software license agreements, sponsorships, educational grants, clinical trials, investigator initiated research, and research collaboration.• Draft and negotiate distribution agreements, power of attorney, regulatory and tender related documents for Latin America and Asia Pacific regions, working closely with Bayer’s local country business heads and legal counsel. • Support the integration of the legacy Radiology business into Bayer’s global structure in legal and compliance matters, coordinating with management control, local business units, finance, supply chain and regulatory groups.• Create global antitrust procedures for the Radiology business at Bayer’s headquarters in Berlin, Germany, Summer 2015.• Review and improvement of legal and compliance policies, procedures and internal training material (e.g. Anti-Corruption/FCPA, PPACA Sunshine Act updates, Independent Research SOP, Commercial Exhibits). • Present updates to senior management on compliance projects and new policies (e.g. CAN-SPAM). • Implement and later evaluate the conformity and efficiency of controls of compliance-driven projects such as Classification of Information, Compliance Hotline, Customer Product Evaluations, etc. Show less

Legal Intern

• Jun 2013 - Jul 2013

• Evaluated existing international distribution agreements worldwide. Reported gaps and compliance risks. Created an action plan in coordination with 40+ local country division heads and the department of international accounts in the US.• Analyzed healthcare transparency legislation in 5 European countries to ensure compliance in upcoming clinical trials for a new product line.

Associate Attorney

• Apr 2011 - Jun 2012

Corporate Law • Drafted and negotiated service and partnership agreements, commercial leases for several clients in the retail business. • Contacted clients regarding upcoming Board of Directors meetings, including agenda preparation, communication and drafting official minutes. • Conducted title searches and analyses on potential areas for copper and silver extraction for a mining industry client. • Studies on land use, roads, easements and waterways for Concha y Toro vineyards. Labor and Employment Law • Second chaired 50+ bench trials involving termination, discrimination and safety. • Conducted collective bargaining negotiations with managing partner on behalf of large retail holdings. • Represented employers in appeals before the Labor Administrative Agency. • Advised employers on C-level issues, such as executive retention, employment agreements, non-competition agreements and severance agreements. • Advised employers on human resources issues such as discriminatory discharge, policy and procedural manuals, gender discrimination and sexual harassment. Show less

Legal Intern

• Oct 2010 - Mar 2011

• Court Appointed Attorney for minors and SENAME’s representative in family law matters such as legal custody, termination of parental rights, and adoption proceedings. • Court Appointed Attorney for minors and SENAME’s representative in family law matters such as legal custody, termination of parental rights, and adoption proceedings.