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 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.