Senior Specialist Regulatory Affairs
hace 2 días
**Overview**
At the heart of QIAGEN’s business is a vision to make improvements in life possible.
We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic, international and diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.
Join us. At QIAGEN, you make a difference every day.
**Position Description**
We are currently searching for a Senior Specialist Regulatory Affairs to join our team in Mexico. The Specialist will provides critical support for IVD product registrations and maintenance globally, represent Regulatory Affairs during the management of the IVD product change process and correspond with Regulatory Authorities on behalf of Regulatory Affairs leadership.
**Key responsibilities include**:
- Compiling, reviewing, and monitoring health registration files for new regulated products following local requirements.
- Ensuring the lifecycle of health records aligns with renewal cycles specified in regulations, as well as, managing the lifecycle of legal regulatory documents for processes like import permits and tenders.
- Analyzing the impact of product change controls and, if needed, compiling, reviewing, and monitoring modification files for health registration in line with local regulations.
- Handling administrative processes and ensuring compliance with local regulatory requirements, including payments, translations, and certified copies.
- Performing impact analyses, risk mitigation, and implementing changes in regulatory procedures in response to local regulatory changes.
**Position Requirements**
- Bachelor's degree in Biology, Chemistry, Pharmacy, Biologist or related field.
- 4 to 5 years of experience with Regulatory Affairs in Medical Devices is required.
- Good verbal/written communication skills.
- Fluent in Spanish language and professional level of English language, written and verbal.
**What we offer**
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.
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.
Job Reference: LATAM00120
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