Senior Specialist Regulatory Affairs

Overview  

 
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible.  

We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams. 
 
We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you. 

At QIAGEN, every day is an opportunity to make a real-life impact. 

Join us, grow with us, and together, let's shape the future of biological discovery. 

About the opportunity

Join QIAGEN’s Regulatory Affairs team supporting Mexico & CAR and play a key role in bringing innovative healthcare solutions to market. As a Senior Specialist Regulatory Affairs, you will ensure regulatory compliance and lifecycle management of in vitro diagnostics (IVD) and medical device products.

Work closely with cross-functional teams including Quality, Operations, Marketing, and Supply Chain, while engaging directly with regulatory authorities such as COFEPRIS. This role offers the opportunity to contribute to product compliance, business continuity, and patient access to cutting-edge diagnostic solutions in a dynamic and highly regulated environment.
This is a hybrid role (4 days office, 1 day home) in our Mexico City office.
 

Your tasks include

• Manage regulatory submissions, including registrations, renewals, and variations for IVD and medical device products

• Prepare, review, and submit regulatory dossiers, ensuring accuracy and compliance with local requirements

• Monitor and assess the regulatory impact of product changes and coordinate necessary actions

• Act as a key contact for regulatory authorities (e.g., COFEPRIS) and accredited third parties

• Ensure availability and validity of regulatory documentation for registrations, import permits, and tenders

• Track regulatory changes, assess risks, and implement mitigation strategies

• Collaborate with cross-functional teams to support projects and improve regulatory processes
   

Your profile

• Degree in Life Sciences (e.g., Pharmacy, Biology, Biotechnology, Biomedical or Chemical Engineering)

• Experience in Regulatory Affairs within medical devices, diagnostics, IVD, or pharmaceutical industry

• Hands-on experience with regulatory submissions, lifecycle management, and compliance processes

• Knowledge of Mexican and Caribbean regulatory requirements (COFEPRIS experience preferred)

• Strong analytical, organizational, and problem-solving skills

• Ability to manage multiple priorities and collaborate in cross-functional teams

• Fluent in English with strong written and verbal communication skills

What we offer  

• Bonus/Commission  

• Local benefits   

• Referral Program  

• Volunteer Day  

• Internal Academy (QIALearn)   

• Employee Assistance Program   

• Hybrid work (conditional to your role) 

Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking.   

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.