Regulatory Affairs Specialist
Aviso de fuente externaen BEPC Inc. - Business Excellence Professional Consulting
Regulatory Affairs Specialist role providing strategic direction and technical leadership in medical device regulatory affairs and global submissions.
Salario
No especificado
Ubicación
Ciudad Juárez, México
Tipo de empleo
Tiempo completo
Modalidad
No especificado
Descripción del empleo
About the role
BEPC Inc. - Business Excellence Professional Consulting 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. - Business Excellence Professional Consulting is seeking a highly experienced regulatory affairs engineer to provide strategic direction and technical leadership in regulatory affairs for medical devices. The role involves global regulatory frameworks, cross-functional initiatives, compliance throughout the product lifecycle, regulatory strategy, team mentoring, submissions, and approvals across global markets. It combines hands-on execution with strategic oversight.
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.
- Interface with agencies such as the FDA, Notified Bodies, and global regulators as the regulatory authority.
- Guide R&D, Quality, and Manufacturing teams on compliance from concept through post-market.
- Lead regulatory audits and readiness activities.
- Evaluate FDA, EU MDR, ISO 13485, and MDSAP requirements and translate them into actionable business strategies.
- Review and approve labeling, packaging, and technical documentation for regulatory compliance.
- Drive continuous improvement in regulatory and quality systems and foster a culture of compliance excellence.
- Identify regulatory risks and implement mitigation strategies aligned with business objectives.
Requirements
- Bachelor’s degree in a scientific, engineering, or related field.
- Deep expertise in global regulatory frameworks and a proven ability to lead cross-functional initiatives.
Datos clave
- The role focuses on regulatory affairs for medical devices.
- A bachelor’s degree in a scientific, engineering, or related field is listed.
- Responsibilities include regulatory strategies, submissions, audits, and compliance.
Preguntas frecuentes
What does this role involve?
It provides strategic direction and technical leadership in regulatory affairs for medical devices, including global regulatory strategy and submissions.
What qualifications are listed?
The source lists a bachelor’s degree in a scientific, engineering, or related field, along with deep expertise in global regulatory frameworks and the ability to lead cross-functional initiatives.
What regulatory frameworks and submissions are mentioned?
The listing mentions 510(k), PMA, IDE, international filings, FDA, EU MDR, ISO 13485, and MDSAP.
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