Regulatory Affairs Engineer – Medical Devices & Launch Lead

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 1.217.179 - 1.564.945; Jornada completa

Descripción de la vacante

BEPC Inc. in Ciudad Juárez is hiring a Regulatory Affairs Staff Engineer to oversee product development compliance and provide regulatory guidance. Key responsibilities include leading submissions for product licenses, ensuring regulatory compliance, and collaborating with cross-functional teams. Candidates should have a Bachelor’s degree and significant experience in regulatory affairs, ideally within the healthcare sector. The position offers a chance to impact product development processes and align them with industry regulations.

Formación

• Bachelor’s degree in science, biomedical engineering, or related field.
• 6 years of regulatory affairs experience or advanced degree with 3 years of related experience.
• Experience in the healthcare products industry is essential.

Responsabilidades

• Provide regulatory guidance during product development and lifecycle management.
• Ensure compliance with regulatory agency guidelines.
• Prepare responses to regulatory questions and submissions.
• Lead submissions of licenses and registrations.
• Collaborate with cross-functional teams for regulatory approvals.

Conocimientos

Regulatory strategy development

Clinical data analysis

Compliance management

Negotiation with regulatory authorities

Scientific and technical understanding

Educación

Bachelor’s degree in science or engineering

6 years of regulatory affairs experience

Descripción del empleo

BEPC Inc. in Ciudad Juárez is hiring a Regulatory Affairs Staff Engineer to oversee product development compliance and provide regulatory guidance. Key responsibilities include leading submissions for product licenses, ensuring regulatory compliance, and collaborating with cross-functional teams. Candidates should have a Bachelor’s degree and significant experience in regulatory affairs, ideally within the healthcare sector. The position offers a chance to impact product development processes and align them with industry regulations.