Regulatory Affairs Specialist

hace 4 semanas


Ciudad Juarez, México BEPC Inc A tiempo completo

**Regulatory Affairs Specialist**
- Develop and maintain regulatory strategies for the development, registration, and commercialization of **medical devices**:

- Communicate with regulatory authorities to obtain timely approvals for medical devices
- Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations
- Monitor regulatory changes and provide guidance to cross-functional teams on potential impact to business
- Participate in cross-functional teams to ensure regulatory compliance throughout the product lifecycle
- Assist with the preparation and conduct of regulatory inspections and audits
- Maintain regulatory files and ensure documentation is up-to-date and accurate

**Qualifications**:

- Bachelor's degree in a scientific discipline
- 3+ years of experience in Regulatory Affairs in the Medical Device industry
- Strong understanding of US and international regulations related to medical devices, including FDA, EU MDR, and other global regulations
- Experience preparing and submitting regulatory filings for medical devices
- Excellent communication, organizational, and analytical skills
- Ability to work independently and in a team environment
- Strong attention to detail and ability to manage multiple projects simultaneously.
- Advanced English 90%

Tipo de puesto: Tiempo completo

Salario: $100.00 - $200.00 al mes

Horario:

- Lunes a viernes

Prestaciones:

- Seguro de gastos médicos mayores



  • Ciudad Juarez, México BEPC Inc A tiempo completo

    Develop and maintain regulatory strategies for the development, registration, and commercialization of medical devices - Communicate with regulatory authorities to obtain timely approvals for medical devices - Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations - Monitor regulatory changes and provide...


  • Ciudad de México Atos A tiempo completo

    **Publication Date**: May 25, 2023 **Ref. No**: 481413 **Location**: Mexico, D.F., Distrito Federal, MX, 2300 The future is our choice At Atos, as the global leader in secure and decarbonized digital, our purpose is to help design the future of the information space. Together we bring the diversity of our people’s skills and backgrounds to make the...


  • Ciudad de México Novartis A tiempo completo

    Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross-functional careers, a diverse learning suite of thousands of programs & an...


  • Ciudad de México Olympus Corporation of the Americas A tiempo completo

    **Workplace Flexibility**:Hybrid** Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together. **Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.** **Our Purpose is to make people’s lives healthier, safer, and more...


  • Ciudad de México IPSEN A tiempo completo

    **Title**: Head of Regulatory Affairs and QA (Mexico & Export markets) **Company**: Ipsen Mexico S de RL de CV Head of Regulatory Affairs and QA (Mexico & Export markets)

  • Regulatory Specialist

    hace 3 días


    Ciudad de México HAYS A tiempo completo

    CDMX Permanent offer Hybrid **Your new company** Leading company in the development and manufacture of consumables for the Printing Industry, is looking for its Regulatory Compliance Specialist. **Your new role** *** You will be responsible of: - Maintain regulatory records, manage and update regulatory system data in various databases. - Prepare data...


  • Ciudad de México AstraZeneca A tiempo completo

    At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. This means we are opening up new ways to work, ground-breaking methods and bringing excellent teams together. Above...


  • Ciudad de México Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to...


  • Ciudad de México Viatris A tiempo completo

    Regulatory Affairs Analyst (Fixed Term) page is loaded Regulatory Affairs Analyst (Fixed Term) Postuler locations Mexico City, Mexico time type Temps plein posted on Offre publiée hier job requisition id R5646189 Viatris Healthcare México S. de R.L. de C.V Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait...


  • Ciudad de México Biogen A tiempo completo

    **Job Description**: **About This Role** Reporting to the Sr. Manager, Regulatory affairs, the Manager supports all regulatory strategies creating tactics for new products at local and global levels. **What you will do**: - Responsible for precise and aligned communication with local teams and global Regulatory team. - Coordinate all post-registration...


  • Ciudad de México Red Bull A tiempo completo

    **Company Description**: The legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering...


  • Ciudad de México Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Regulatory Affairs

    hace 7 días


    Benito Juarez, México Boston Scientific A tiempo completo

    Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...


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

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...


  • Ciudad de México AbbVie A tiempo completo

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...


  • Ciudad de México Red Bull Gruppe A tiempo completo

    The legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering technical and legal...

  • Regulatory Affairs

    hace 7 días


    Benito Juarez, México Boston Scientific A tiempo completo

    Additional Locations:  N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...


  • Ciudad de México Pfizer A tiempo completo

    Why Patients Need You We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...


  • Ciudad Juarez, México Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...


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

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...