Punë
Regulatory Affairs Specialist
Sonova AG
regulatory-affairs-specialist-usort2
Andrijevica, Montenegro
Prodhim
Përshkrimi
**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).
Paga: $400k - $500k per year
Burimi: https://jobs.sonova.com/job/_/1448690433/
# 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).
Paga: $400k - $500k per year
Burimi: https://jobs.sonova.com/job/_/1448690433/
Kërkesat
Niveli: senior
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