Experience

Oscor Inc.

• United States
• Medical Device
• 100 - 200 Employee

• Regulatory Affairs Manager

  • May 2021 - Present

• Regulatory Affairs Specialist

  • May 2019 - Feb 2022

  Assist in preparing regulatory submissions for domestic or international projects. Provide internal training on regulatory procedures and guidelines. Participate in product development activities such as new product design and change control. Maintain knowledge base of existing and emerging regulations, standards, or guidance documents. Creates and monitors regulatory project schedules to meet product launch timelines. Assist in maintaining global product regulatory compliance by reviewing… Show more Assist in preparing regulatory submissions for domestic or international projects. Provide internal training on regulatory procedures and guidelines. Participate in product development activities such as new product design and change control. Maintain knowledge base of existing and emerging regulations, standards, or guidance documents. Creates and monitors regulatory project schedules to meet product launch timelines. Assist in maintaining global product regulatory compliance by reviewing design changes, labeling, advertising and promotional materials. Coordinate on-going regulatory activities with Corporate Quality and Engineering. Communicate with domestic and international business partners as needed. Exercise judgment within defined procedures and practices to determine appropriate regulatory action. Recommend changes to improve practices and procedures



Johnson & Johnson

• Guaynabo, PR

• Sr. Regulatory Affairs Specialist (Medial Group)

  • Jun 2017 - May 2019

  Process excellence cluster and RA local investigation lead. Perform criticality assessment at technical files (documents and labels) and design dossier (medical devices). Ensure that IMDRF is followed in conformance with regional requirements. Provide support and complete LATAM, Asia Pacific, Europa countries design dossiers requirements for new products introduction & line extension. Develops and maintains SOP’s to ensure compliance with project scope and dossier excellence requirements Process excellence cluster and RA local investigation lead. Perform criticality assessment at technical files (documents and labels) and design dossier (medical devices). Ensure that IMDRF is followed in conformance with regional requirements. Provide support and complete LATAM, Asia Pacific, Europa countries design dossiers requirements for new products introduction & line extension. Develops and maintains SOP’s to ensure compliance with project scope and dossier excellence requirements



Amgen (BES Consulting)

• Juncos, Puerto Rico

• Regulatory Affairs Advisor

  • Jul 2016 - Jun 2017

  Perform criticality assessments to change controls, non-conformances and CAPA’s to determine impact on product regulatory filling / registrations CTA/MA, PMF, DMF and FMA. Authoring and revision of CMC products filling and variations for multiple markets/jurisdictions; to products annual reviews and related documents to ensure adherence with regulatory requirements. Provide training to associate partners. Perform criticality assessments to change controls, non-conformances and CAPA’s to determine impact on product regulatory filling / registrations CTA/MA, PMF, DMF and FMA. Authoring and revision of CMC products filling and variations for multiple markets/jurisdictions; to products annual reviews and related documents to ensure adherence with regulatory requirements. Provide training to associate partners.



Zimmer Biomet

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Regulatory Affairs Specialist

  • Jul 2014 - Jul 2016

  •Coordinates the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. •Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions. •Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. •Evaluate risk of proposed regulatory strategies; may offer solutions. •Reviews… Show more •Coordinates the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. •Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions. •Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. •Evaluate risk of proposed regulatory strategies; may offer solutions. •Reviews proposed labeling for compliance with applicable US and international regulations. •Manages the process of writing package inserts. •Reviews and evaluates promotion and advertising material for compliance with applicable regulations. •Reviews proposed product changes for impact on regulatory status of the product. •Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization. •Establishes Zimmer RA policy and procedures. •May provide training and/or guidance to new entry-level associates. •Monitor and handle business quality holds, quality holds, field notifications and quality management system international requests.

• Sr. Quality Compliance Auditor

  • Feb 2014 - Jul 2016

  Sr. Compliance & Quality Auditor Zimmer Manufacturing B.V – PR 2014 to present •Perform assessment of Zimmer quality system worldwide to determine whether the quality system is in compliance with the established requirements and to evaluate its effectiveness. •Audit areas of the quality system, such as development and manufacturing. •Creates audit checklists based on assigned areas, applicable regulations, quality system and/or procedural requirements. •Evaluates the adequacy… Show more Sr. Compliance & Quality Auditor Zimmer Manufacturing B.V – PR 2014 to present •Perform assessment of Zimmer quality system worldwide to determine whether the quality system is in compliance with the established requirements and to evaluate its effectiveness. •Audit areas of the quality system, such as development and manufacturing. •Creates audit checklists based on assigned areas, applicable regulations, quality system and/or procedural requirements. •Evaluates the adequacy and compliance of systems operations and practices against regulations and company documentation. •Formulates and documents nonconformities and obtains concurrence with responsible management. •Track issues through to closure including reviewing the corrective action taken. •Provides work direction to audit team. •Communicates final results of audits to responsible management during formal management debriefs. •Writes reports of audit results, obtains approval and publishes results to responsible management. •Oversees follow up of corrective actions and audit closure, including escalating overdue items as necessary. •Serves as escort to inspector or assessors from regulatory agencies or notified bodies. •Certified as CAPA investigator and conducts investigations as required. •Responsible for verification of CAPA effectiveness. •Leads six-sigma project initiatives. •Writes and improves procedures to address compliance groups •Supervise lower level compliance auditors.



Warner Chilcott

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Quality System Materials Management

  • Jun 2013 - Feb 2014

  • Responsible for ensuring conformance with cGMPand SOP’s related to materials suppliers’ qualifications. Perform initial assessments for potential new suppliers or changes to existing materials / suppliers. • Assesses the Quality System status and audit requirements including questionnaire and audit responses to determine compliance with business standards. • Communicates to Site Quality Management any material/provider quality issues to determine immediate actions. • Monitors… Show more • Responsible for ensuring conformance with cGMPand SOP’s related to materials suppliers’ qualifications. Perform initial assessments for potential new suppliers or changes to existing materials / suppliers. • Assesses the Quality System status and audit requirements including questionnaire and audit responses to determine compliance with business standards. • Communicates to Site Quality Management any material/provider quality issues to determine immediate actions. • Monitors material/suppliers quality performance. • Administrate the Approved and Experimental suppliers list. • Supports the preparation of Quality Agreement s relative to any new and/or change in commercial or non –commercial material in order to ensure evaluation of data. • Provide in-puts in the Global Change Control forum relative to material changes. • Supports unplanned and planned deviations related to materials / suppliers issues. • Interacts with internal and external resources at high management level involving a clear strategic vision, quality and time to market focus and well negotiation skills. Show less • Responsible for ensuring conformance with cGMPand SOP’s related to materials suppliers’ qualifications. Perform initial assessments for potential new suppliers or changes to existing materials / suppliers. • Assesses the Quality System status and audit requirements including questionnaire and audit responses to determine compliance with business standards. • Communicates to Site Quality Management any material/provider quality issues to determine immediate actions. • Monitors… Show more • Responsible for ensuring conformance with cGMPand SOP’s related to materials suppliers’ qualifications. Perform initial assessments for potential new suppliers or changes to existing materials / suppliers. • Assesses the Quality System status and audit requirements including questionnaire and audit responses to determine compliance with business standards. • Communicates to Site Quality Management any material/provider quality issues to determine immediate actions. • Monitors material/suppliers quality performance. • Administrate the Approved and Experimental suppliers list. • Supports the preparation of Quality Agreement s relative to any new and/or change in commercial or non –commercial material in order to ensure evaluation of data. • Provide in-puts in the Global Change Control forum relative to material changes. • Supports unplanned and planned deviations related to materials / suppliers issues. • Interacts with internal and external resources at high management level involving a clear strategic vision, quality and time to market focus and well negotiation skills. Show less



Stryker

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality & Regulatory Compliance Advisor – Project Manager

  • Feb 2010 - Jun 2013

  • RoHS Corporate SPR Project Manager: SPR Endoscopy / Instrument products compliance. Lead project scope and related activities to comply with European Regulation. Project Management supplier assessment and compliance declarations. • IEC 60601 3rd Edition Project Manager: Implement standard for medical electrical equipment for CE mark approval. • REACH regulation gap assessment, project plan definition. Project Management supplier assessment and compliance declarations. • MPR /… Show more • RoHS Corporate SPR Project Manager: SPR Endoscopy / Instrument products compliance. Lead project scope and related activities to comply with European Regulation. Project Management supplier assessment and compliance declarations. • IEC 60601 3rd Edition Project Manager: Implement standard for medical electrical equipment for CE mark approval. • REACH regulation gap assessment, project plan definition. Project Management supplier assessment and compliance declarations. • MPR / Stryker: Compliance Project: Design and Implement Type I & II Device History Records. Revise and consolidate operational and quality forms and procedures. Revise and validate testing methods with standards. • MDD 2007/047/EC Project implementation leader: perform packaging and sterilization gap assessment to SPR Endoscopy (Arthroscopy, Fluids and Cutters BU), procedures revision, devices labels material (product/shipping label(s) & IFU), and utilized Agile for change(s) and activities management. Project Management supplier assessment and compliance declarations. • Validation assessment (procedures, technical reports, DHR CR, QA Testing Methods & Labeling, Suppliers, Components). Design and implement CR FW DHR Class II product. Consolidate and reformat Quality and Process procedures and forms. • CAPA Leader – Mix Up products. Define & coordinate activities with project team members. Establish timeline and resources; follow up business units supervisors and engineers. Show less • RoHS Corporate SPR Project Manager: SPR Endoscopy / Instrument products compliance. Lead project scope and related activities to comply with European Regulation. Project Management supplier assessment and compliance declarations. • IEC 60601 3rd Edition Project Manager: Implement standard for medical electrical equipment for CE mark approval. • REACH regulation gap assessment, project plan definition. Project Management supplier assessment and compliance declarations. • MPR /… Show more • RoHS Corporate SPR Project Manager: SPR Endoscopy / Instrument products compliance. Lead project scope and related activities to comply with European Regulation. Project Management supplier assessment and compliance declarations. • IEC 60601 3rd Edition Project Manager: Implement standard for medical electrical equipment for CE mark approval. • REACH regulation gap assessment, project plan definition. Project Management supplier assessment and compliance declarations. • MPR / Stryker: Compliance Project: Design and Implement Type I & II Device History Records. Revise and consolidate operational and quality forms and procedures. Revise and validate testing methods with standards. • MDD 2007/047/EC Project implementation leader: perform packaging and sterilization gap assessment to SPR Endoscopy (Arthroscopy, Fluids and Cutters BU), procedures revision, devices labels material (product/shipping label(s) & IFU), and utilized Agile for change(s) and activities management. Project Management supplier assessment and compliance declarations. • Validation assessment (procedures, technical reports, DHR CR, QA Testing Methods & Labeling, Suppliers, Components). Design and implement CR FW DHR Class II product. Consolidate and reformat Quality and Process procedures and forms. • CAPA Leader – Mix Up products. Define & coordinate activities with project team members. Establish timeline and resources; follow up business units supervisors and engineers. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Compliance Services

  • 2008 - 2010

• Regulatory Conformance Consultant

  • 2007 - 2008

  Duties are related but not limited to perform a comprehensive and comparative analysis for processes, systems and organizations to maintain compliance with Affiliates other markets for Global Product Conformance (GPC) program to ensure that Wyeth products released to global markets are in compliance with the associated Marketing Authorization or relevant regulatory requirements. The program will sustain a robust change control processes for Chemistry, Manufacturing & Controls (CMC) and Artwork… Show more Duties are related but not limited to perform a comprehensive and comparative analysis for processes, systems and organizations to maintain compliance with Affiliates other markets for Global Product Conformance (GPC) program to ensure that Wyeth products released to global markets are in compliance with the associated Marketing Authorization or relevant regulatory requirements. The program will sustain a robust change control processes for Chemistry, Manufacturing & Controls (CMC) and Artwork & Labeling. Quality system tools use: computer systems such as Trackwise and SAP, GroupWise, Product Dossier Management, EDMS, etc. Create standard operating procedures for system and process suitability

• Quality Assurance Specialist – Operational Excellence Specialist

  • 2006 - 2008

  •Duties are related but not limited to define, revise, and investigate manufacturing discrepancies related to the Manufacturing, Engineering and Packaging PPU. •Conduct investigations, identify root causes, CAPA, scope, identify areas for improvements, processes and impact assessment to quality according with procedures, specifications and related regulations to assure compliance and submit status / metrics reports. •Define process improvement projects tools, provide technical… Show more •Duties are related but not limited to define, revise, and investigate manufacturing discrepancies related to the Manufacturing, Engineering and Packaging PPU. •Conduct investigations, identify root causes, CAPA, scope, identify areas for improvements, processes and impact assessment to quality according with procedures, specifications and related regulations to assure compliance and submit status / metrics reports. •Define process improvement projects tools, provide technical, functional and compliance guide during discrepancies investigation, and establish business impact and assessment for critical areas. Define and establish Manufacturing PPU, Engineering and Packaging PPU progress report, which and area for improvements



Fluor Corporation

• United States
• Construction
• 700 & Above Employee

• Senior Engineer

  • 2001 - 2008

• Senior Engineering Validation Specialist – Project Manager

  • 2001 - 2004

  Duties are related but not limited to develop, perform and manage validation activities schedule and budget for EPCV projects to assure compliance with regulations.



Cordis LLC, San German, PR – ReComs

• Third Party Senior Quality & Regulatory Consultant

  • 2004 - 2006

  •Duties are related but not limited to define supplier qualification and receiving inspection strategies and material specifications for business consumables. Define and develop plant logistic and delineate implementation plans & safety area improvement. Research and develop of new processes to concur with business requirements, design procedures and validate new process equipment. Provide technical support, schedule project activities. •Duties are related but not limited to provide… Show more •Duties are related but not limited to define supplier qualification and receiving inspection strategies and material specifications for business consumables. Define and develop plant logistic and delineate implementation plans & safety area improvement. Research and develop of new processes to concur with business requirements, design procedures and validate new process equipment. Provide technical support, schedule project activities. •Duties are related but not limited to provide guide and assistance during manufacturing process, production areas audits and audit production batch records & related documentation to concur with regulations. Identify non-conformities considering regulations statutes that affect product performance, quality and final disposition. Evaluate and approve business / process / production non-conformances according with procedures, specifications and related regulations to assure compliance and submit project status / metrics reports. Show less •Duties are related but not limited to define supplier qualification and receiving inspection strategies and material specifications for business consumables. Define and develop plant logistic and delineate implementation plans & safety area improvement. Research and develop of new processes to concur with business requirements, design procedures and validate new process equipment. Provide technical support, schedule project activities. •Duties are related but not limited to provide… Show more •Duties are related but not limited to define supplier qualification and receiving inspection strategies and material specifications for business consumables. Define and develop plant logistic and delineate implementation plans & safety area improvement. Research and develop of new processes to concur with business requirements, design procedures and validate new process equipment. Provide technical support, schedule project activities. •Duties are related but not limited to provide guide and assistance during manufacturing process, production areas audits and audit production batch records & related documentation to concur with regulations. Identify non-conformities considering regulations statutes that affect product performance, quality and final disposition. Evaluate and approve business / process / production non-conformances according with procedures, specifications and related regulations to assure compliance and submit project status / metrics reports. Show less



Cordis

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Third party - RA/QA advisor

  • 2002 - 2006