Role at a glance
- Job function
-
Legal & Compliance Compliance & Regulatory Affairs
- Salary
- Not Disclosed
- Location
- Mexico City, Mexico
- Work arrangement
- Remote
- Employment
- Full-time
- Experience
- Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of experience in regulatory affairs, preferably in IVD/medical device industry
- Education
- Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of experience in regulatory affairs, preferably in...
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Role Summary
The Regulatory Affairs Specialist II supports product compliance and market access for diagnostic solutions. The role works with cross-functional teams on regulatory submissions, product registrations, and quality management systems across global markets.
What You'll Do
- Ensure product compliance and market access for diagnostic solutions.
- Manage regulatory submissions with cross-functional teams.
- Maintain product registrations across global markets.
- Support quality management systems across global markets.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of experience in regulatory affairs; comprehensive knowledge of global regulatory requirements, particularly FDA, EU IVDR/MDR, and regional regulations; strong understanding of quality management systems (ISO 13485, GMP, MDSAP); experience preparing and reviewing technical documentation and regulatory submissions; expertise in product lifecycle management and change control; ability to interpret and apply regulatory requirements; project management, organizational, analytical, problem-solving, written and verbal communication, documentation, and prioritization skills; fluency in English; proficiency in Microsoft Office and regulatory information management systems; ability to work in a matrix organization and cross-functional teams; experience with post-market surveillance and vigilance reporting.
Preferred
- Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field
- Additional regulatory affairs certifications beneficial
- Additional languages beneficial
- Experience in the IVD/medical device industry preferred
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.DESCRIPTION:
Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II, where you'll ensure product compliance and market access for our innovative diagnostic solutions. You'll work with cross-functional teams to manage regulatory submissions, maintain product registrations, and support quality management systems across global markets. This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.
REQUIREMENTS:
• Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of experience in regulatory affairs, preferably in IVD/medical device industry
• Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field
• Additional regulatory affairs certifications beneficial
• Comprehensive knowledge of global regulatory requirements, particularly FDA, EU IVDR/MDR, and regional regulations
• Strong understanding of quality management systems (ISO 13485, GMP, MDSAP)
• Experience preparing and reviewing technical documentation and regulatory submissions
• Expertise in product lifecycle management and change control processes
• Proven ability to interpret and apply regulatory requirements to product development and maintenance
• Excellent project management and organizational skills
• Strong analytical and problem-solving capabilities
• Superior written and verbal communication skills
• Fluency in English required; additional languages beneficial
• Proficiency in Microsoft Office and regulatory information management systems
• Ability to work effectively in a matrix organization and cross-functional teams
• Detail-oriented with strong documentation skills
• Demonstrated ability to manage multiple priorities and meet deadlines
• Experience with post-market surveillance and vigilance reporting
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.