BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries.
BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.At BEPC Inc., we are looking for a Regulatory Affairs Staff Engineer with deep expertise in end-to-end responsibility for the life cycle maintenance and new product development launches within the portfolio.
Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches.
Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.Also helps define data and information needed for regulatory approvals in conjunction with cross-functional product development teams and assists in identification and development of best practices for Regulatory Affairs processes.Key ResponsibilitiesProvide input and guidance during New Product Development and Lifecycle Management projects,



including regulatory strategy and supporting evidence including clinical dataEnsure compliance with regulatory agency regulations and interpretationsGather and assemble information necessary for submissions in accordance with regulations and relevant guidelinesPrepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvalsCommunicate, negotiate, and maintain rapport with regulatory reviewers to identify pre-submission requirements and ensure submission strategy alignmentProvide solutions to complex problems requiring evaluation of variablesLead submission of licenses and authorizations for maintenance of existing products, international registrations, and dossiersGuide conformance with applicable regulations in product development, claims support, and label contentDefine data and information needed for regulatory approvalsCollaborate in development and approval of labeling after evaluating conformance to regulationsProvide Regulatory Affairs support during internal and external auditsPlan schedules for regulatory deliverables and monitor projects through completionAssist in development of best practices for Regulatory Affairs processes and systemsRepresent Regulatory Affairs and provide regulatory advice on cross-functional teamsPartner with other functions to obtain data for regulatory submissionsCommunicate business-related issues or opportunities to next management levelEnsure compliance with Health, Safety,



and Environmental practices (if managing staff)Ensure personnel and company compliance with all regulations, policies, and proceduresPerform other duties as assigned.Work with the Operations and Design team to verify and validate that the product under development meets regulatory and design requirements.Main QualificationsBachelor's degree in science, biomedical engineering, medical/scientific writing, public health administration and 6 years of regulatory affairs or related experience OR advanced degree (M.S., M.E., Ph.D. or M.D.) with minimum 3 years of related experienceExperience in healthcare products industry including submissionsLeverages deep scientific and technical understanding of regulated productsAbility to integrate and execute results-oriented regulatory strategies aligned with organizational objectivesAbility to define and prioritize decision criteria, assess risks and benefits, and make decisions in ambiguous situationsAbility to manage complex information from multiple sources and make timely decisionsBuilds and leverages internal and external networksEngages with regulatory agencies, industry groups, and government agenciesAbility to deliver results with speed, flexibility, and accountabilityPreferred QualificationsExperience with clinical development (strongly preferred)Previous medical device submission experience for medium and high-risk devices (preferred)Demonstrated track record of leadership success (strongly preferred)Experience leading multi-functional teams (preferred)Experience with combination products (preferred)Experience working and negotiating with regulatory bodies desirable
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📌 Regulatory Affairs Staff Engineer (Medical Industry) (Ciudad Juárez)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Ciudad Juárez