Regulatory Affairs Specialist

hace 4 semanas


Buenos Aires, Argentina ITEX A tiempo completo
About the Company

Our client is a pioneering force in the medical and aesthetic device industry, renowned for its innovative products and commitment to excellence. With a global presence and a team of dedicated professionals, we strive to push the boundaries of what is possible in healthcare.

Job Overview

As a Regulatory Affairs Specialist, you will play a vital role in ensuring the compliance of our medical devices with regulatory requirements across various markets. This position requires close collaboration with regulatory bodies, internal departments, and customers to manage product registrations, maintain technical documentation, and support compliance processes. Your work will directly contribute to the global market access of innovative medical and aesthetic devices, ensuring product safety and regulatory integrity.

Key Responsibilities
  • Ensure regulatory compliance of medical devices across different countries
  • Coordinate and prepare product registrations and notifications within deadlines
  • Communicate with regulatory authorities for product registrations and updates
  • Prepare and maintain technical files and other regulatory documents
  • Legalize documents and certificates through notary offices and embassies for product approvals
  • Provide support to customers with product data and regulatory information
  • Ensure compliance for product exports, including managing Certificates of Origin
  • Collaborate with marketing, purchasing, and engineering teams to meet regulatory requirements
  • Handle the issuance of Free Sale Certificates and other required regulatory documents
  • Support the registration of Economic Operators in the EUDAMED database
  • Translate regulatory documents between Slovak and English when necessary
  • Ensure compliance with organizational quality, environment, and health and safety standards
Requirements
  • Academic degree in life sciences, chemistry, or technical/engineering education
  • 2+ years of experience in a similar regulatory affairs position
  • Knowledge of regulatory issues and experience interfacing with local and international regulatory bodies
  • Advanced computer skills (MS Office)
  • Experience in medical writing is an advantage
  • English: Advanced (C1)
  • Slovak: Proficiency (C2)
What We Offer
  • Competitive salary
  • 13th salary in Q1 based on both company profits and individual employee performance
  • Reimbursement for commuting expenses
  • Great office environment and team culture
  • Long-term contract with the potential for growth

We are committed to creating innovative products that make a difference in people's lives. Join us and be part of a dynamic team that is shaping the future of healthcare.



  • Buenos Aires, Argentina ITEX A tiempo completo

    About ITEX: Our company is a global leader in producing high-tech medical and aesthetic devices, known for their use of valuable materials and sophisticated design. With offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, this international company is at the forefront of innovation in its field.Job Overview:As a...

  • Regulatory Affairs Lead

    hace 2 semanas


    Buenos Aires, Buenos Aires C.F., Argentina AbbVie A tiempo completo

    Job Summary: We are seeking a highly experienced Regulatory Affairs Specialist to join our team at AbbVie. As a Regulatory Affairs Specialist, you will be responsible for developing and executing regulatory strategies in alignment with Global and Affiliate Regulatory colleagues.Key Responsibilities:Develop and execute regulatory strategies to ensure...


  • Buenos Aires, Argentina Medtronic A tiempo completo

    **Careers that Change Lives **In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA...


  • Buenos Aires, Argentina ITEX A tiempo completo

    About the CompanyOur client is a leading global manufacturer of high-tech medical and aesthetic devices, renowned for their innovative products and commitment to quality. With a presence in multiple countries, including the USA, UK, Bratislava, and India, this international company is at the forefront of innovation in its field.Job OverviewAs a Regulatory...


  • Buenos Aires, Argentina Boston Scientific A tiempo completo

    About the RoleWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Boston Scientific. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.Key ResponsibilitiesValidate license control of ARG and legal status of...


  • Buenos Aires, Argentina Boston Scientific A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Boston Scientific. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the quality and safety of our medical devices.Key ResponsibilitiesValidate License Control of ARG + Legal status of...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...


  • Buenos Aires, Argentina AbbVie A tiempo completo

    **Company Description** **Major Responsibilities**: - Provides strategic direction to support the development of compliant and competitive Regulatory programs; - Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities; - Effectively...


  • Buenos Aires, Buenos Aires C.F., Argentina AbbVie A tiempo completo

    Role SummaryThe Regulatory Affairs Specialist will develop and execute regulatory strategies in alignment with Global and Affiliate Regulatory colleagues as appropriate. The role represents Area on the Global Regulatory Product Teams (GRPTs) and leads Area Regulatory Product Teams (ARPTs) to identify and compile the information necessary to register and...

  • Regulatory Affairs

    hace 5 meses


    Buenos Aires, Argentina International Flavors & Fragrances A tiempo completo

    This position is key and strategic to the Global Regulatory Affairs organization to meet the strategy to be a premier partner to our customers. Customers need detailed information about our products, quality systems, 3rd party certifications, regulatory compliance and others. In this role you will be responsible to deliver documentation; answering inquiries...


  • Buenos Aires, Buenos Aires C.F., Argentina ITEX A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ITEX. As a key member of our global regulatory team, you will play a crucial role in ensuring the compliance of our medical devices with international regulations and standards.Key ResponsibilitiesEnsure regulatory compliance of medical devices across various...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    Introduction/Purpose The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and...


  • Buenos Aires, Buenos Aires C.F., Argentina ITEX A tiempo completo

    About ITEX: Our company is a leading global developer of cutting-edge medical and aesthetic devices. We have offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries.**Job Overview:** As a Regulatory Affairs Specialist, you will play a critical role in ensuring that our medical devices comply with all applicable regulations...


  • Buenos Aires, Argentina Haleon A tiempo completo

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Corega, Centrum, Alikal, Uvasal, Hinds - through a unique combination of deep human understanding...


  • Buenos Aires, Argentina Haleon A tiempo completo

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Corega, Centrum, Alikal, Uvasal, Hinds – through a unique combination of deep human...


  • Buenos Aires, Argentina ITEX A tiempo completo

    About the Company: Our client is a global leader in producing high-tech medical and aesthetic devices, known for their use of valuable materials and sophisticated design. With offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, this international company is at the forefront of innovation in its field.Job Overview:As a...


  • Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

    **Regulatory Affairs Coordinator - Argentina**: - Work mode: Hybrid- Onsite Location(s): Buenos Aires, Argentina**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...


  • Buenos Aires, Argentina Haleon A tiempo completo

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Corega, Centrum, Alikal, Uvasal, Hinds - through a unique combination of deep human understanding...