Regulatory Affairs Specialist

Sonova Group; México; On-site; MXN 60,000 - 90,000; Full time

Job summary

Sonova México is seeking a Regulatory Affairs Specialist to ensure compliance with health regulations and support commercialization of our medical device products in Mexico.

You will work with internal teams and COFEPRIS, manage registrations, labeling reviews, and regulatory submissions to keep supply uninterrupted.

Qualifications

• Bachelor’s degree in a health-related field or equivalent.
• 2+ years of Regulatory Affairs experience with medical devices and COFEPRIS.
• Knowledge of Mexican medical device legislation and COFEPRIS requirements.
• Advanced English proficiency.

Responsibilities

• Prepare and compile documentation for medical device sanitary registrations.
• Prepare applications for import/export permits and advertising notices.
• Manage regulatory submissions and COFEPRIS interactions with authorities.
• Review product labeling for compliance with Mexican regulations.
• Support the quality management system and technovigilance processes.
• Collaborate with Operations and Sales to ensure regulatory planning and supply continuity.
• Liaise with regulatory agencies and customs for notifications and actions.

Skills

Regulatory Affairs

English proficiency

Microsoft Office

Communication skills

Time management

Education

Bachelor's degree in health-related field

Diploma/Master's/Regulatory Affairs certificate

Tools

COFEPRIS digital platforms

Job description

Select how often (in days) to receive an alert:

At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

Regulatory Affairs Specialist

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.

What we offer:

• Benefits in accordance with the Federal Labor Law (LFT).

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.