Senior Specialist Regulatory Affairs

hace 5 meses


Ciudad de México Qiagen A tiempo completo

**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



  • Ciudad de México, CDMX Icon plc A tiempo completo

    Senior Regulatory Affairs Specialist - Mexico City - Office with Flex ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development JR123070 Senior Regulatory...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a Regulatory Affairs Specialist, you will be responsible for managing post-approval activities for the Canadian market, including life cycle management, change controls, and regulatory submissions.Key Responsibilities:Manage...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    In this role as a Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...


  • Ciudad de México, Ciudad de México 520 ICR Mexico - MEX A tiempo completo

    Job Title: Senior Regulatory Affairs Specialist with Experience in Clinical TrialsJob Summary:We are seeking a Senior Regulatory Affairs Specialist to join our team at 520 ICR Mexico - MEX. As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.Key...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    We are seeking a Regulatory Affairs Specialist to contribute to ensuring the delivery of regulatory activities on a global level.Key Responsibilities:To assist in the production of client administrative documents for regulatory submissions.To compile regulatory dossiers in accordance with national requirements and ensure their accuracy.To manage systems and...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Job DescriptionWe are seeking a highly skilled Global Regulatory Affairs Specialist to ensure the delivery of regulatory activities on a global level. This role requires strong organizational and interpersonal skills, with excellent oral and written communication abilities.


  • Ecatepec de Morelos, México Philips A tiempo completo

    **Job Title**: Regulatory Affairs SpecialistAt Philips, we're committed to improving billions of lives worldwide through innovation. As a Regulatory Affairs Specialist, you'll play a crucial role in ensuring our medical and non-medical products meet regulatory requirements in Mexico and Latin America.**Key Responsibilities:**Communicate Mexico-specific...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    We are seeking a Regulatory Affairs Specialist to ensure the delivery of regulatory activities on a global level.Key ResponsibilitiesContribute to the production of client administrative documents for regulatory submissions.Compile regulatory dossiers in accordance with national requirements.Manage systems and administer regulatory processes.Track and...


  • Ciudad de México, Ciudad de México Qiagen A tiempo completo

    Regulatory Affairs Manager RoleWe are seeking an experienced Regulatory Affairs Manager to lead and undertake regulatory responsibility for Mexico and Central Americas to ensure our IVD products comply with regional regulations and laws.This role involves developing and implementing regulatory strategies to facilitate product approvals, registrations, and...


  • Ciudad de México, Ciudad de México ICON Plc A tiempo completo

    Senior Regulatory Affairs Specialist with a strong track record in Clinical TrialsAt ICON Plc, we're seeking an experienced Regulatory Affairs Specialist to join our team. This role will be responsible for leading the preparation, submission, and maintenance of regulatory documents for clinical trials.Provide expertise and guidance on regulatory requirements...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    In the context of a new project, we are seeking a Regulatory Affairs Specialist to support our teams in Mexico/LATAM.Key ResponsibilitiesProvide guidance and support on Mexican and Central America legislation.Contribute to regulatory activities, including pre-licensing, new registrations, and post-licensing submissions.Assist in the production of client...


  • Ciudad de México, Ciudad de México Solventum A tiempo completo

    Job Description:Regulatory Affairs Specialist, Mexico (Solventum)Solventum is a company committed to innovation and excellence in the healthcare sector. We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico.Key Responsibilities:Provide regulatory support for medical products sold in Mexico, including managing licenses with...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    Are you a public affairs and relations expert with a passion for the pharmaceutical industry? We are seeking a Senior Public Affairs Specialist to lead our External Affairs department at Novo Nordisk. As a key member of our team, you will maintain and enhance our positive relations with external audiences, including the general public, shareholders,...


  • Ciudad de México, Ciudad de México Gilead Sciences A tiempo completo

    Job Title: Regulatory Affairs Senior ManagerAbout the Role:We are seeking a highly skilled Regulatory Affairs Senior Manager to join our team at Gilead Sciences. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulatory requirements.Key...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    Position for Novo Nordisk GBS MexicoPursue a challenging career in regulatory affairs with Novo Nordisk's Global Business Service Centre in Mexico City.We are seeking a highly skilled Regulatory Affairs Coordinator to support the compilation, submission, and approval of Country Specific Submissions files for responsible countries.Key ResponsibilitiesSupport...


  • Ciudad de México, Ciudad de México Solventum A tiempo completo

    Job OverviewSolventum is seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico. As a Regulatory Affairs Specialist, you will be responsible for providing general regulatory support for medical products sold in Mexico, including managing medical product licenses with COFEPRIS, reviewing and approving product labeling and...


  • Ciudad de México, Ciudad de México Solventum A tiempo completo

    Improve Healthcare with SolventumSolventum is a company dedicated to enhancing healthcare by pioneering game-changing innovations at the intersection of health, material, and data science. As a Regulatory Affairs Specialist, you will be part of our team that ensures every solution created for our customers' toughest challenges adheres to the highest...


  • Ciudad de México, Ciudad de México Icon Plc A tiempo completo

    The Regulatory Affairs Specialist will contribute to the preparation, compilation, and submission of regulatory documents, including CT/IND, MAA, and NOA. Key Responsibilities:- Regulatory Document Preparation: Prepare and submit regulatory documents in a timely and accurate manner.- Collaboration with Teams: Work with the Regulatory Submissions team and...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    In a pivotal role at Thermo Fisher Scientific, the Sr Regulatory Affairs Specialist will be part of our Regulatory Liaison team, spearheading communications with regulatory agencies as part of centralized regulatory submissions. This includes collaboration with regulatory affairs leads to provide strategic guidance and technical/project leadership on a...


  • Ciudad de México, Ciudad de México Mccormick & Company A tiempo completo

    **Scientific and Regulatory Affairs Manager LATAM**Mccormick & Company, a world leader in the spice, flavor and seasonings industry, is seeking a full time Scientific and Regulatory Affairs Manager LATAM. This new hire will work in our Mexico City location.We create differentiating flavors consumers prefer with unmatched quality, science, innovation and...