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