Regulatory Affairs Staff Engineer (Medical Industry)

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 RESPONSABILITIES:

• 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 submission of licenses and authorizations for maintenance of existing products, international registrations, and dossiers
• Guide conformance with applicable regulations in product development, claims support, and label content
• Define data and information needed for regulatory approvals
• Collaborate in development and approval of labeling after evaluating conformance to regulations
• Provide Regulatory Affairs support during internal and external audits
• Plan schedules for regulatory deliverables and monitor projects through completion
• Assist in development of best practices for Regulatory Affairs processes and systems
• Represent Regulatory Affairs and provide regulatory advice on cross-functional teams
• Partner with other functions to obtain data for regulatory submissions
• Communicate business-related issues or opportunities to next management level
• Ensure compliance with Health, Safety, and Environmental practices (if managing staff)
• Ensure personnel and company compliance with all regulations, policies, and procedures
• Perform 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 QUALIFICATIONS:

• Bachelor’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 experience
• Experience in healthcare products industry including submissions
• Leverages deep scientific and technical understanding of regulated products
• Ability to integrate and execute results-oriented regulatory strategies aligned with organizational objectives
• Ability to define and prioritize decision criteria, assess risks and benefits, and make decisions in ambiguous situations
• Ability to manage complex information from multiple sources and make timely decisions
• Builds and leverages internal and external networks
• Engages with regulatory agencies, industry groups, and government agencies
• Leadership skills leveraging diverse perspectives
• Ability to deliver results with speed, flexibility, and accountability

PREFERRED QUALIFICATIONS:

• Experience 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)
• RAC (Regulatory Affairs Certification) desirable
• Experience working and negotiating with regulatory bodies desirable