Regulatory Affairs Specialist

Sonova is hiring a Regulatory Affairs Specialist in Mexico City, Mexico. It pays $400k-$500k a year and Level rates it ; you can apply on Sonova.

Level's read on this job

On Level's scale, this role is Little AI ●○○○: aI is not part of the work.
Level classifies it as a mid-level role.
Level lists 397 other open roles at Sonova.

AI in this role

Mexico City, México – Hybrid

Regulatory Affairs Specialist

At Sonova México, we are looking for a Regulatory Affairs Specialist to help ensure compliance with applicable health regulations and support the commercialization of our medical device products in Mexico.

In this role, you will work closely with internal teams and external regulatory agencies, with a strong focus on COFEPRIS requirements and Mexican medical device regulations.

Responsibilities:

Prepare and compile documentation for medical device sanitary registrations, including renewals and modifications.
Prepare applications for import and export permits, as well as documentation for advertising permits and notices.
Manage and follow up on regulatory submissions and procedures with COFEPRIS.
Review product labeling and help ensure compliance with applicable Mexican laws, regulations, and official standards for medical devices.
Support the quality management system and the evaluation, follow-up, and resolution of technovigilance incidents.
Partner closely with Operations and Sales to support product supply continuity through discontinuation monitoring and regulatory planning.
Serve as a liaison with external regulatory agencies and customs agents to help resolve import holds and regulatory notifications.

More about you:

Completed bachelor’s degree, preferably in a health-related field.
Diploma, master’s degree, or certificate related to Regulatory Affairs.
At least 2 years of Regulatory Affairs experience with medical devices and COFEPRIS.
Knowledge of Mexican medical device legislation.
Advanced English proficiency.
Intermediate proficiency with Microsoft Office; experience using COFEPRIS digital platforms is a plus.
Excellent communication and organizational skills, a service-oriented mindset, and strong time-management abilities.

Don't meet all the criteria? If you're willing to go all in and learn, we'd love to hear from you!

Annual Salary: MXN $400,000 – $500,000

What we offer:

Benefits in accordance with the Federal Labor Law (LFT).
Savings Fund (Fondo de Ahorro).

How we rate this

Regulatory Affairs Specialist at Sonova rates 36 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.