VIRIDIANA Blas

Experienced in the Medical Devices and Health, with a proven track record of effectively leading teams and achieving operational excellence. Expertise lies in implementing strategic initiatives that significantly improve productivity and efficiency within organizations. Strong problem-solving and decision-making ability, consistently finding innovative solutions to challenges and driving positive outcomes. Throughout career, successfully managed teams and delivered results, making a valuable asset to any organization seeking a dedicated professional with a solid history of driving operational success.

• 2023- 12/2024 SR
• RAQA MANAGER STRYKER - Mexico City, Mexico
• Task:
• Led cross-functional teams to ensure compliance with regulatory standards and quality management systems, including ISO 13485 and FDA 21 CFR
• Managed end-to-end regulatory submissions and approvals across LATAM
• Streamlined processes for post-market surveillance to enhance operational efficiency
• Fostered collaboration with stakeholders to improve alignment and achieve regulatory objectives
• Drove the timely implementation of QPulse updates and strengthened risk management practices
• Developed metrics dashboards to support strategic decision-making
• Mentored team members and promoted a culture of continuous improvement in regulatory and quality practices
• Achievements:
• Recognized as the best country for Regulatory Affairs performance in the LATAM region, earning a prestigious regional award for excellence
• Implemented and led a cross-functional innovation committee, fostering collaboration to develop creative solutions and streamline processes
• Spearheaded the re-certification of ISO 13485 and ISO 9001 standards, achieving compliance without any non-conformities (NCs)
• Demonstrated ability to deliver results, inspire innovation, and uphold the highest standards in regulatory and quality management.2021 -07/2023 REGULATORY AFFAIRS, QUALITY ASSURANCE AND COMPLIANCE MANAGER MEDARTIS - Mexico City, Mexico Tasks: Implement and support the quality management system, post market surveillance, licenses, and compliance duties in Mexico to comply with current regulations
• 04/2017 - 03/2021 Achievements:
• Complete submission of the pipeline under delay to COFPERIS in a record time
• Implementation of critical procedures (compliance, and quality)
• Diagnostic and alignment of current procedures that need to be aligned with corporate and local regulations
• QUALITY ASSURANCE MANAGER
• TELEFLEX MEDICAL - Mexico City, Mexico
• Tasks: Implement and support the quality management system, post market surveillance, and EHS program (Environment, Health & Safety) for Mexico City and LATAM
• Achievements:
• Implementation of the post-market surveillance unit with automation response under SAP in compliance with national and international standards Phase II for certifying Mexico City Office under ISO 13485-2016
• Improvement of critical processes such as customer complaints with automation control responses in SAP/Salesforce, warehousing, cost of poor quality and suppliers management., educational regional program for "think quality, think teleflex" culture as a personal initiative
• Satisfactory implementation of the Environment, Health & Safety Program
• Obtained inclusion an strategic product for the national basic formulary
• Speaker for the DEI (diversity, equality, and inclusion) program 2015 - 01/2017
• RA & PRODUCT STEWARDSHIP COORDINATOR
• BASF - Mexico City, Mexico
• Tasks: Maintain sanitary registrations and implement product stewardship programs all along Mexico
• Achievements:
• Implementation of the stewardship department in Mexico aligned with international and local regulations for high risks molecules
• Desgined programs and trained different type of customers under environmental and health protection regulations
• Actively been in contact with COFEPRIS for fasting procedures and work with GAP (high performance groups) with COFEPRIS and reviewed around 70 procedures that were running under delay for an average of 4 months with all licenses approved
• 2015 - 08/2015
• REGULATORY AFFAIRS COORDINATOR
• PATIA BIOPHARMA - Mexico City, Mexico
• Tasks: Maintain sanitary registrations, implement the quality system & post- market surveillance unit Achievements:
• Implementation of the surveillance unit
• Established the structure of the quality system as well I had participated under the standardization procedure for a metabolomics test with Laboratorios Ruiz in Puebla
• Obtained licenses for new products using third parties 2012 - 01/2015
• REGULATORY AFFAIRS COORDINATOR MEXICO & ROLA
• BIO-RAD- Mexico City, Mexico
• Tasks: Maintain sanitary registrations (renewals, preventions, import permits, and all related activities), for all the product portfolio of four divisions in Mexico and ROLA
• Achievements:
• Almost the 70% of registrations of IHD in a short period of time (new division) Implementation a new site at the intranet which has help to maintain the communication with the corporative about products registrations status in Mexico & ROLA
• Implementation of an automatized documental system based on Good Documental Practices
• 2010 - 07/2012
• REGULATORY AFFAIRS RESPONSIBLE
• SMITH&NEPHEW - Mexico City, Mexico
• Tasks: Maintain sanitary registrations (renewals, preventions, import permits, and all related activities), for all the product portfolio of four divisions, and keep quality systems for warehouse in Mexico from products coming from Europe, Canada, U.S.A, and China
• Achievements:
• We were able to launch 4 different international projects which have significant increased the sales in Mexico with a short period of time for product registration and were the first country in LSA to do so
• Moreover, I have installed a techno-surveillance unit which was under MoH process approval
• Established the quality systems for the warehouse in conformity with international and local legislations
• I have participated on the homology of BRIC´s SOPs, which was an international enterprise project
• I have been representative of the company in local chambers like AMID for which I have put around 36 S&N products under a national low-risk list, so they registrations were simplified
• As well, I have put some necessities under New Mexican Dispositions which were priority for Smith & Nephew
• I have also implemented a documental system for the Regulatory Affairs Department
• 2009 - 08/2010
• CHEMISTRY ASSISTANT
• SUNPHARMA - Mexico City, Mexico
• Tasks: translate, adapt, and maintain SOP & BMRs, in accordance with ICH, FDA guidelines, General Health Law, Pharmacopeias-BP, FEUM, USP, IP, and current Mexican laws for the manufacturing oncology products site in Mexico, and to maintain psychotropic drugs sanitary registrations and warehouse control for the same
• Achievements:
• We got national GMPs for the manufacturing site and all registrations for products were achieved
• 2007 - 08/2008
• MANUFACTURING ASSISTANT
• ANTÍGENOS ALERGOMEX - Mexico City, Mexico
• Tasks: Maintain the process over the allergenic extracts & vaccines manufacturing lines, have control over all bacterial & fungal cultures, and to make all SOPs for GMPs certifications
• Achievements:
• 40 % of total SOP´s were done and all costumers orders were deliver on time 2006 - 08/2007
• MANUFACTURING ASSISANT
• EXTRACTOS ALERGENICOS FREEMAN - Mexico City, Mexico
• Tasks: Maintain the process over the allergenic extracts & vaccines productions lines, and have control over all bacterial & fungal cultures
• Achievements:
• Products were delivered on time for all our customers and according to their necessities (otorhinolaryngologists & allergologist)
• SKILLS
• Leadership
• Team development Risk Management
• Decision making based on objective data
• Associate engagement
• Goverment negotations
• INDUSTRIAL CHAMBERS & ASSOCIATIONS
• CANIFARMA ( FEB 2018 – FEB 2019 )
• PAPS ONBOARD VICEPRESIDENT
• Tasks: Coordinate on board national projects for the medical device guild with different national and international authorities
• Achievements: workshops were developed and agreements were set with the financial national authorities
• Also, I had been a representative for the field for negotiations with national sanitary authorities in regards to standard 241 updates
• CANIFARMA ( AUG 2017 - FEB 2018 )
• PAPS REGULATORY VICEPRESIDENT
• Tasks: Represent and defend the medical device guild regulatory proposals with different national and international authorities
• Achievements: We have achieved good acceptance with COFEPRIS during the Standard 240 review period
• We are also working with NAFTA and the Pacific Alliance medical devices chapter for mutual license recognition
• COLEGIO DE QUIMICOS FARMACEUTICOS BIOLOGOS
• SPEAKER
• ASOCIACION MEXICANA DE FARMACOVIGILANCIA Y
• TECNOVIGILANCIA
• SPEAKER
• AMCHAM, CANACINTRA & AMID
• Enterprise representative and had achieved different national projects due to international guidelines harmonization over the national ones in order to facilitate health administrative procedures for promote international inversion to our country
• PROCYT
• Active member at Campo Limpio and PROCCYT which main purpose was to review and change local standards when needed for agrochemicals
• ADDITIONAL EXPERIENCE
• UNIVERSIDAD NACIONAL AUTONOMA DE MEXICO/ FACULTAD DE
• QUIMICA ( APR 2017 - 2021 )
• Academic Tutor and thesis director
• To guide bachellor´s students during their last semester in order to gain experience and knowledge
• This activity is count as a subject for their major
• Ongoing 5 thesis for bachelor degree under medical devices topics
• COUNCIL FOR SIX SIGMA CERTIFICATION
• Lean-Six Sigma Black Belt Certification on going

ISO 13485:2016 Auditor BSI