Job Title

BEPC Inc. provides Specialized Engineering services to Fortune 500 companies in the Life Science and Technology industries. BEPC Ingenieria, a division of BEPC Incorporated, provides and manages consulting services for medical device companies throughout Mexico.BEPC Inc. is seeking a highly experienced Regulatory Affairs Engineer to provide strategic direction and technical leadership in regulatory affairs for medical devices. This role is ideal for a senior-level professional who brings deep expertise in global regulatory frameworks and a proven ability to lead cross-functional initiatives, ensuring compliance throughout the entire product lifecycle.The ideal candidate will operate as a subject matter expert, influencing regulatory strategy, mentoring teams, and driving successful submissions and approvals across global markets. This position requires both hands-on execution and high-level strategic oversight.KEY RESPONSIBILITIES:Define and lead regulatory strategies for medical device registration and commercialization.Oversee and approve regulatory submissions, including 510(k), PMA, IDE, and international filings.Act as the regulatory authority interfacing with agencies such as the FDA, Notified Bodies, and global regulators.Provide strategic guidance to cross-functional teams (R&D, Quality, Manufacturing) to ensure compliance from concept through post-market.Lead regulatory audits and readiness activities, ensuring successful outcomes.Evaluate and interpret evolving regulatory requirements (FDA, EU MDR, ISO 13485, MDSAP) and translate them into actionable business strategies.Review and approve labeling, packaging, and technical documentation for regulatory compliance.Drive continuous improvement initiatives in regulatory and quality systems, fostering a culture of compliance excellence.Identify regulatory risks and implement mitigation strategies aligned with business objectives.BASIC qualificationsBachelor’s degree in a scientific, engineering, or related discipline (MBA or advanced degree preferred).5+ years of experience in Regulatory Affairs within the medical device industry.Extensive knowledge of global regulatory frameworks, including FDA (21 CFR Part 820), EU MDR, ISO 13485, and MDSAP.Proven experience leading complex regulatory submissions and global approvals.Strong background in quality systems, audits, CAPA, and compliance programs.Demonstrated leadership experience managing cross-functional teams and influencing senior stakeholders.Excellent communication, analytical, and strategic thinking skills.Ability to manage multiple high-impact projects in a fast-paced environment.PREFERRED:Certifications such as ASQ CQA, RAC, or Six Sigma (Green/Black Belt).Experience leading regulatory strategy at a site or enterprise level.Background in audit leadership and regulatory inspection management.