Global Medical Device Regulatory & QA Consultant

UL, LLC; Mexique; À distance; MXN 450 000 - 700 000; Plein temps

Résumé du poste

UL Solutions seeks a Quality and Regulatory Affairs Consultant to join Emergo’s regulatory affairs team, supporting global consulting services and assisting with regulatory and compliance issues. May liaise with local partners and authorities as needed.

You will help prepare and submit medical device registrations, handle renewals and amendments, and advise on submission requirements. The role requires 2–5 years in QA/Regulatory Affairs for medical devices and strong English skills.

Qualifications

• Bachelor's degree in medical, engineering or science.
• Advanced, professional-level written and verbal English.
• 2–5 years of QA/Regulatory Affairs experience in medical devices.
• Consulting experience is a plus.
• Proficient in Microsoft Office.
• Strong multitasking and prioritization skills.

Responsabilités

• Assist with preparation and submission of medical device registrations to regulatory markets.
• Prepare renewals or amendments and support project leads.
• Develop knowledge of registration requirements and process phases.
• Review client documentation and perform gap analysis for submissions.
• Escalate regulatory issues to senior experts as appropriate.
• Prepare regulatory reports.
• Liaise with local regulatory authorities on behalf of clients when needed.
• Act as regulatory support on multi-stakeholder project teams.
• Follow UL Code of Conduct and security practices.

Connaissances

Regulatory affairs

Quality assurance

Medical device knowledge

Microsoft Office

Attention to detail

Project coordination

English communication

Formation

Bachelor's degree in Medical, Engineering or Science

Outils

Microsoft Office

Description du poste

UL Solutions seeks a Quality and Regulatory Affairs Consultant to join Emergo’s regulatory affairs team, supporting global consulting services and assisting with regulatory and compliance issues. May liaise with local partners and authorities as needed.

You will help prepare and submit medical device registrations, handle renewals and amendments, and advise on submission requirements. The role requires 2–5 years in QA/Regulatory Affairs for medical devices and strong English skills.