12 ago
|
BEPC Inc. - Business Excellence Professional Consulting
|
Ciudad Juárez
12 ago
BEPC Inc. - Business Excellence Professional Consulting
Ciudad Juárez
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 Responsibilities
- Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and supporting evidence including clinical data
- Ensure compliance with regulatory agency regulations and interpretations
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
- Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals
- Communicate, negotiate, and maintain rapport with regulatory reviewers to identify pre-submission requirements and ensure submission strategy alignment
- Provide solutions to complex problems requiring evaluation of variables
- Lead su
📌 Regulatory Affairs Staff Engineer (Ciudad Juárez)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Ciudad Juárez