Found Description
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.
**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, Notif...