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 general 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 qualifications

- Bachelor’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.

📌 Regulatory Affairs Specialist (Chihuahua)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Chihuahua