Having worked and taken many responsibilities within the regulatory affairs area has helped me to contribute and belong to a world class company, which promotes a continual improvement process, providing added value service to every single operation. Thus, collaborating with Global Consulting Firms within regulatory affairs area has allowed me to acquire new knowledge about the aforementioned
Having worked and taken many responsibilities within the regulatory affairs area has helped me to contribute and belong to a world class company, which promotes a continual improvement process, providing added value service to every single operation. Thus, collaborating with Global Consulting Firms within regulatory affairs area has allowed me to acquire new knowledge about the aforementioned profession.
As per my interests, I want to expand my professional knowledge of the Regulatory Affairs field by seeking new challenges and facilitating approval, registration, and distribution of medical device and IVD products to be in compliance with the Government agencies.
As attested by my resume, the experience acquired from my current and previous employments have helped me to increase my skills and competences, such as being capable of establishing good long term relationships with others, learn how to work in a team, achieving tasks in the appropriate deadlines, handling multiple priorities with a high sense of urgency, experience reading, understanding and applying regulations to constantly change environment, effective interpersonal and negotiation/persuasion skills and as a result of the previous characteristics, I have enjoyed a reputation of being an efficient-competent student and professional employee.
SENIOR Regulatory Affairs Specialist Core Spine /INTERNATIONAL @ Manage international strategy into regulatory plans supporting new product development and global commercial release.
Develop partnership with divisional international marketing to define appropriates regulatory strategies for international product registrations (new submissions and existing registrations).
Monitor the regulatory environment. Stay abreast of changes in regulations throughout all major international geographies.
Monitor emerging international issues and identify solutions.
Function as the International Regulatory Subject Matter Expert for the assigned business unit products.
Collaborates with in-country personnel to identify global regulatory requirements for International product registrations.
Maintenance and oversight current regulatory filings, renewals, variations, including providing support for change control assessments and submissions
Assesses scientific data against regulatory requirements. Interprets and ensures compliance with applicable regulations. Assists with coordination and ongoing training of Regulatory Affairs staff.
Prepares market authorizations and responses to questions from regulatory agencies in collaboration with other companies such as contract manufacturers/organizations, other Medtronic subsidiaries, and cross functional teams. Prepares and reviews data from research and manufacturing reports, without direct supervision.
Develop regulatory strategies to present information in assigned regulatory submissions to optimize the reviewability by the Health Authority.
Evaluation, revision and feedback on the submissions worldwide.
Provide input to budget, planning, and evaluation processes.
Participate as needed with field actions including assisting with the creation of plans and reports, action execution, and regulatory agency interaction.
Act as a point of contact for International Regulatory teams.
Support the New Product Submission Planning process for worldwide product registrations. From May 2015 to Present (8 months) Greater Memphis AreaSENIOR Regulatory Affairs Specialist Core Spine /LATIN AMERICA AND BRAZIL @ • Responsible for developing submission plans for assigned projects and provides input for RA strategy to facilitate approval of new products in Latin America Countries.
• Coordinates and guidance in interpreting and implementing US and international regulations.
• Prepare submissions for new products and product changes as required to ensure timely approvals for market release.
• Interact with Marketing, Engineering, Clinical Affairs, Operations and Quality Assurance to develop new products according to the company’s New Product Development Process.
• Prepare submissions to obtain approvals to commercially distribute products.
• Provides expertise in document packages for regulatory submissions from all areas of company (regulatory and cross-functional teams).
• Collaborate on internal audits and inspections.
• High level of management of regulatory functions throughout Initial submissions, licenses renewals and annual registrations.
• Prepares registration packages, responds to deficiency letters, government questions, and sustains existing Licenses to support revenue.
• Assesses scientific data against regulatory requirements.
• Strategic role representing the regulatory perspective ensuring compliance for changes, labeling, manufacturing, marketing, within the regulatory framework.
• Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes.
• Coordinates and guidance in ongoing training of Regulatory Affairs staff.
• Direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals based on submission pathways- Analysis.
• Support product registrations for international markets as required. From April 2014 to May 2015 (1 year 2 months) Greater Memphis AreaRegulatory Affairs Specialist Core Spine/Kyphon/Biological devices @ Responsible for staying abreast of evolving regulatory requirements in specific areas of concentration (countries) as needed. Manage interactions with various regulatory agencies, regional affiliates and distributors.
Prepare submissions for new products and product changes as required to ensure timely approvals for market release. Responsible for formulating, communicating, applying and developing regulatory strategies and timelines handling submissions and obtaining approval to introduce medical devices and therapies to the Mexican market.
Monitor/ interpret latest regulatory environment assessing impact to existing business procedures and practice.
Ensure compliance and compliant growth of the business by providing strategic and tactical regulatory
support addressing issues/opportunities with alternatives to achieve desired outcomes through the interpretation and application of relevant laws, regulations, guidelines, and company policies.
Coordinate receipt of technical information from appropriate sources and manage the preparation of submissions for new products, amendment/variation of approved products and submissions that support the maintenance of existing licenses. Review Scientific and technical data intended for submission ensuring the compliance with the regulatory requirements, providing guidance to marketing and design teams.
Manage the preparation and maintenance of moderate-complexity regulatory submissions, prepare responses to standard questions and comments from regulatory agencies and ensure issues are addressed in a timely manner.
Provide regulatory support for new products and changes to existing products by working with RAS team in Country to resolve potential regulatory issues and questions from regulatory agencies.
Follow up on regulatory procedures to ensure compliance and high quality work.
Performs other duties as assigned. From December 2012 to May 2014 (1 year 6 months) Regulatory Affairs @ •Maintenance for RA files in compliance with regulations.
•Medical device and IVD Registration in Mexico:
Submissions for a wide range of medical devices- Standard & fast track routes (FDA/Canada/Japan),
Submissions of renewals ensuring appropriates deadlines,
Submissions of technical/administrative modifications to the current registrations as needed based on the product- type of change involved.
Submission of Importation Licenses including verification during the whole process; follow up on future shipments being supported by International Commerce department.
•Collaborate on translations of technical documentation when is required.
•Determine classification of medical devices based on Mexican guidelines.
•Follow up on requirements and documentation according to government agencies.
•Support and guidance to national and International Customer Service.
•Maintain contact with 3rd parties involved as necessary: the 3rd parties authorized by Cofepris to expedite the registration process, worldwide consultants, certified translation firms, translators.
Audits to local warehouses based on local government guidelines.
Support/assistance- Medical Distributor Qualification in Mexico. From September 2010 to December 2012 (2 years 4 months) Regulatory Affairs @ •Management assistant in the Central America’s facilities sites research to create a database to maintain an update records per product.
•Translations: Technical files, Certificates of Analysis, and relevant documentation in accordance to the internal company’s guidelines.
•Periodically review of Legal/apostilled documents in order to maintain the most current versions in place. From 2010 to 2010 (less than a year) Quality Assurance (analytical support & chemical control) @ •Assistance in Annual Products Review’s process including final reports per finished product evaluating the deviations occurred during the manufacturing process to prevent future troubles and risks in their quality.
•Assistance in the development of a master file compiling the required analytical procedures and protocols per API.
•Translations: USP/BP monographs for raw materials, finished products techniques and SOP’s.
•Assistance on trend analysis per product obtaining key information to evaluate potential risks that might impact in the quality process.
•Coordination with 3rd parties (laboratories) to perform testing based on CCAYAC-COFEPRIS guidelines. From 2008 to 2010 (2 years)
Pharmaceutical Chemistry and Biology/ Q.F.B.- Químico Farmaceutico Biologo, Pharmaceutical Sciences @ Universidad Del Valle From 2006 to 2010 Silvia Morales Cruz is skilled in: ISO 13485, Regulatory Affairs, Medical Devices, FDA, PMA, CAPA, Regulatory Submissions, Medical Device Directive, IVD, Quality System, GMP, Complaint Management, Quality Auditing, Regulatory Requirements, Lean Manufacturing
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