Regulatory Affairs Associate

hace 1 día

Ciudad de México, Ciudad de México ClinChoice A tiempo completo

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts.  

Job Title: Regulatory Affairs Associate - CONSULTANT

Location: Mexico; Remote

Responsibilities:

  • Support planning and project management across Regulatory Affairs, serving as the key liaison with global stakeholders
  • Leverage data analytics, metrics, and insights to organize regulatory information, demonstrate value, and enable informed decision-making across the business
  • Collect, review, and upload product, licensed product and license data in databases (e.g., UDI, eligibility, etc.)
  • Review, execute and drive eligibility releases as per required procedures
  • Review, track and monitor critical Notified Body mailbox and invoices
  • On a project/product basis, facilitate change orders for DEC/DoC/DD and other documents in the PLM system(s), and assist with strategy creation, follow-up on local assessments and creation of relevant documentation (e.g., letters to file)
  • Maintain/update in all relevant databases and sources (e.g., GRID for document self-serve)
  • On a project basis, monitor, track and execute regulatory operational processes as required
  • Perform other tasks as required

Minimum Requirements:

  • Bachelor's degree (life sciences preferred)
    • Knowledge of EU MDD/MDR, ISO13485, US FDA QSR
    • Proven ability to manage and track multiple regulatory projects and timelines
    • Strong data analytics skills with experience using metrics, dashboards, and reporting to drive decisions and demonstrate value
    • Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint)
    • Strong proficiency in written and verbal English communication is required.

Key Words: Regulatory Affairs, data analysis, EU MDD, EU MDR, ISO 13485, US FDA QSR

#LI-PB1 #LI-REMOTE

  • Sr. Regulatory Affairs Associate- CONSULTANT

    hace 1 día

    Ciudad de México, Ciudad de México ClinChoice A tiempo completo

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….ClinChoice is searching for a Sr. Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our...

  • CMC Regulatory Affairs Profesionals

    hace 2 semanas

    Ciudad de México, Ciudad de México Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

  • Regulatory Affairs Coordinator

    hace 1 semana

    Ciudad de México, Ciudad de México Novo Nordisk, Inc. A tiempo completo

    Regulatory Affairs CoordinatorCategory: Reg Affairs & Safety PharmacovigilanceLocation:Ciudad de México, Ciudad de México, MXRegulatory AffairsMexico City, MexicoAre you passionate about regulatory compliance and ensuring patient safety? Do you have experience navigating complex regulatory landscapes and working with global stakeholders? If so, we invite...

  • Regulatory Affairs Manager

    hace 2 semanas

    Ciudad de México, Ciudad de México Eli Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Experienced Analyst Regulatory Affairs

    hace 2 días

    Ciudad de México, Ciudad de México Johnson & Johnson Innovative Medicine A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Experienced Analyst Regulatory Affairs

    hace 2 días

    Ciudad de México, Ciudad de México Johnson & Johnson A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...

  • Regulatory Affairs Coordinator

    hace 2 semanas

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

    Regulatory AffairsMexico City, MexicoAre you passionate about regulatory compliance and ensuring patient safety? Do you have experience navigating complex regulatory landscapes and working with global stakeholders? If so, we invite you to join our team as a Regulatory Affairs Coordinator in Mexico City. Apply today and make a difference in the lives of...

  • Experienced Analyst Regulatory Affairs

    hace 2 días

    Ciudad de México, Ciudad de México Johnson & Johnson Innovative Medicine A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Regulatory Affairs Lead

    hace 2 semanas

    Ciudad de México, Ciudad de México Viatris A tiempo completo

    Viatris Healthcare México S. de R.L. de C.VAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:  Access – Providing high quality trusted...

  • Regulatory Affairs Lead

    hace 2 semanas

    Ciudad de México, Ciudad de México Viatris A tiempo completo

    Viatris Healthcare México S. de R.L. de C.VAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access – Providing high quality trusted...