Regulatory Affairs Specialist

hace 4 semanas


Madrid, Madrid, España ITEX A tiempo completo

About ITEX: As a global leader in producing high-tech medical and aesthetic devices, we strive to innovate and push the boundaries of what is possible. Our commitment to quality and regulatory compliance is unwavering, and we are seeking a skilled Regulatory Affairs Specialist to join our team.

Job Overview: As a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our medical devices comply with all applicable regulations and standards across various markets. This role requires close collaboration with regulatory bodies, internal departments, and customers to manage product registrations, maintain technical documentation, and support compliance processes.

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


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory Affairs SpecialistAs a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our clinical trials with regulatory requirements. Your responsibilities will include providing regulatory guidance throughout the clinical development life cycle, compiling and coordinating applications to Regulatory Authorities, and...


  • Madrid, Madrid, España Ventos A tiempo completo

    Regulatory Affairs Specialist Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ventós Group in Sant Just Desvern, Barcelona. As a Regulatory Affairs Specialist, you will play a key role in maintaining our product database, collaborating with suppliers to homologate new products, preparing technical documentation, and...


  • Madrid, Madrid, España Ventos A tiempo completo

    We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ventós Group. As a key member of our international company, you will be responsible for maintaining our product database, collaborating in the homologation of new products and suppliers, and preparing technical documentation for our products.As a Regulatory Affairs Specialist,...


  • Madrid, Madrid, España Ergomed A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Ergomed, a leading global clinical research organization. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.


  • Madrid, Madrid, España Zentiva Group, a.s. A tiempo completo

    Job Title: Regulatory Affairs SpecialistThe Regulatory Affairs Specialist at Zentiva Group, a.s. is accountable for managing the Regulatory Affairs agenda at country level. This includes providing an efficient and proactive Regulatory service to meet business objectives, supporting commercialization of products, ensuring agility in daily interaction with...


  • Madrid, Madrid, España Johnson And Johnson A tiempo completo

    Regulatory Affairs SpecialistJohnson and Johnson is seeking a skilled Regulatory Affairs Specialist to join our team in Madrid. This role offers a hybrid working model and is an exciting opportunity to contribute to our company's mission to build a world where complex diseases are prevented, treated, and cured.Key ResponsibilitiesSupport the growth of our...


  • Madrid, Madrid, España Alk-Abelló AS A tiempo completo

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Alk-Abelló A/S. As a key member of our regulatory team, you will be responsible for handling CMC documentation for products manufactured at our site in Madrid, ensuring compliance with local and regional requirements.Key Responsibilities:Coordination and...


  • Madrid, Madrid, España Ramboll Group AS A tiempo completo

    We are seeking a highly skilled Regulatory Affairs Specialist to support our clients in navigating the complex landscape of European regulations governing product safety and stewardship.The ideal candidate will have a deep understanding of REACH, BPR, and other relevant regulations, as well as excellent communication and collaboration skills.As a key member...


  • Madrid, Madrid, España Iqvia A tiempo completo

    Regulatory Affairs Role OverviewAs a Regulatory Affairs Specialist at IQVIA, you will play a critical role in supporting clinical trial and marketing authorization activities for both internal and external clients. Your expertise will be instrumental in preparing and reviewing regulatory submissions to ensure compliance with regulatory requirements.Key...


  • Madrid, Madrid, España Alk-Abelló AS A tiempo completo

    We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Alk-Abelló A/S. As a world leader in allergy, our aspiration is to provide options for prevention, diagnosis, and treatment of allergy, helping as many people as possible to a better life.Key responsibilities include handling regulatory CMC documentation for products...


  • Madrid, Madrid, España Precision Medicine Group A tiempo completo

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Spain. This role will be responsible for delivering site activation readiness within assigned countries/sites and ensuring compliance with international and local regulations.The ideal candidate will have a strong understanding of clinical trial regulations,...


  • Madrid, Madrid, España Pharmalex A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmalex. The successful candidate will be responsible for the preparation, revision, and compilation of informative texts for healthcare professionals and patients in the EU and non-EU markets.Key Responsibilities:Participate in the development of target...


  • Madrid, Madrid, España Kenvue A tiempo completo

    Regulatory Affairs InternAt Kenvue, we are committed to delivering high-quality products that meet the highest standards of safety and efficacy. As a Regulatory Affairs Intern, you will play a critical role in ensuring compliance with regulatory requirements and maintaining our competitive edge in the market.Key Responsibilities:Regulatory Affairs:...


  • Madrid, Madrid, España Ferring Pharmaceuticals A tiempo completo

    Job Description: Ferring Pharmaceuticals seeks a Quality Assurance & Regulatory Affairs Specialist to support and contribute to the Quality and Regulatory Affairs team. Key responsibilities include managing the company's system of procedures, preparing and reviewing SOPs, and monitoring submitted variations to obtain approvals. Requirements:- Health Sciences...


  • Madrid, Madrid, España Kenvue A tiempo completo

    Come be part of a dynamic team at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.Job Description - Regulatory Affairs InternAt Kenvue, we realize the extraordinary power of everyday care. Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and...


  • Madrid, Madrid, España Pharmalex A tiempo completo

    Job SummaryAs a Regulatory Affairs Specialist at PharmaLex, you will be responsible for the preparation, revision, and compilation of informative texts for healthcare professionals and patients in the EU and non-EU markets. This includes the development of target product/labelling profiles and the management of creation and maintenance of CCDS/CCSI/RSI, as...


  • Madrid, Madrid, España Kenvue A tiempo completo

    We are seeking a talented Regulatory Affairs Intern to join our team at Kenvue. As a Regulatory Affairs Intern, you will play a key role in ensuring the compliance of our products with regulatory requirements in Spain.Key Responsibilities:Coordinate and submit new drug applications, cosmetics, medical devices, food supplements, or similar products to...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory Manager Job DescriptionWe are seeking a highly skilled Regulatory Manager to join our team at Precision for Medicine (CRO). The successful candidate will provide regulatory strategy and development guidance for optimal conduct of clinical trials, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with...


  • Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completo

    Regulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures. This role ensures timely preparation of well-organized, quality regulatory submissions in compliance with...