Senior Regulatory Affairs Specialist

hace 7 días


Alcobendas, Madrid, España Stryker Group A tiempo completo

Job Summary

The Senior Regulatory Affairs Specialist will be responsible for implementing and improving Stryker's regulatory and post-market surveillance system, quality management system, and environmental management system in Iberica. The focus will be on ensuring the safety of healthcare professionals and patients who come into contact with the company's medical device products.

Key Responsibilities

  • Collaborate in the management and maintenance of regulatory, vigilance, and quality management processes, including product field actions, holds, SOPs, audits, CAPAs, OEMs, training, product registration, and certifications.
  • Maintain a good relationship with Competent Authorities and internal and external customers.
  • Ensure that systems and actions are put in place according to European regulations, country-specific legislation, and quality management certification requirements.
  • Provide technical and scientific support to the team.

Requirements

  • Fluent in English and Spanish. Portuguese will be a plus.
  • Degree graduate in a science, engineering, or business field, or no less than 2-3 years of experience working in QA/RA for a medical device or pharmaceutical organization.
  • Proven expertise in ISO 9001 quality management systems, ISO, and MDD vigilance and notification processes.
  • Good communication and team working skills, analytical and customer service skills, and ability to prioritize and organize own workload.

About Stryker Group

Stryker Group is a leading medical technology company that develops and manufactures medical devices and equipment. The company is committed to improving healthcare outcomes and enhancing the quality of life for patients around the world.



  • Alcobendas, Madrid, España Stryker Group A tiempo completo

    About the RoleThe Stryker Group is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Madrid. As a key member of our Quality Management team, you will be responsible for implementing and improving our regulatory and post-market surveillance system, ensuring the safety of healthcare professionals and patients who come into...


  • Alcobendas, Madrid, España Stryker Group A tiempo completo

    About the RoleThe Stryker Group is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Madrid. As a key member of our Quality Management team, you will be responsible for implementing and improving our regulatory and post-market surveillance system, ensuring the safety of healthcare professionals and patients who come into...


  • Alcobendas, Madrid, España Stryker A tiempo completo

    Job SummaryThe Senior Regulatory Affairs Specialist will be responsible for implementing and improving Stryker's regulatory and post-market surveillance system, quality management system, and environmental management system in Iberica. This role will ensure the safety of healthcare professionals and patients who come into contact with the company's medical...


  • Alcobendas, Madrid, España Stryker A tiempo completo

    Job SummaryThe Senior Regulatory Affairs Specialist will be responsible for implementing and improving Stryker's regulatory and post-market surveillance system, quality management system, and environmental management system in Iberica. This role will ensure the safety of healthcare professionals and patients who come into contact with the company's medical...


  • Alcobendas, Madrid, España Stryker A tiempo completo

    About the RoleThe Senior Regulatory Affairs Specialist will play a key role in ensuring the safety and quality of Stryker's medical device products. This position will be responsible for implementing and improving the company's regulatory and post-market surveillance system, as well as the Quality Management system and Environmental management system in the...


  • Alcobendas, Madrid, España Stryker A tiempo completo

    About the RoleThe Senior Regulatory Affairs Specialist will play a key role in ensuring the safety and quality of Stryker's medical device products. This position will be responsible for implementing and improving the company's regulatory and post-market surveillance system, as well as the Quality Management system and Environmental management system in the...


  • Alcobendas, Madrid, España Stryker A tiempo completo

    Job SummaryThe Senior Regulatory Affairs Specialist will be responsible for implementing and improving Stryker's regulatory and post-market surveillance system, the Quality Management system, and the Environmental management system in Iberica.Key ResponsibilitiesEnsure the safety of healthcare professionals and patients by assuring that good distribution...


  • Alcobendas, Madrid, España Stryker A tiempo completo

    Job SummaryThe Senior Regulatory Affairs Specialist will be responsible for implementing and improving Stryker's regulatory and post-market surveillance system, the Quality Management system, and the Environmental management system in Iberica.Key ResponsibilitiesEnsure the safety of healthcare professionals and patients by assuring that good distribution...

  • Regulatory Affairs Lead

    hace 4 semanas


    Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

    Company Overview:Precision Medicine Group is seeking a skilled Regulatory Affairs Lead to enhance our team. This role is open to candidates from various locations.Position Overview:The Regulatory Affairs Lead (RAL) is responsible for providing strategic regulatory direction and development support to ensure the effective execution of clinical trials,...


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

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Precision Medicine Group. As a key member of our regulatory team, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and...


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

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Precision Medicine Group. As a key member of our regulatory team, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    At Parexel, we believe in the power of shared values to drive success. Parexel, a premier Clinical Research Organization (CRO), is in search of a distinguished Senior Regulatory Affairs Advisor (Associate Director level) with a strong background in Chemistry, Manufacturing, and Controls (CMC) for biological products and/or vaccines. The successful...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Parexel. As a key member of our regulatory team, you will play a vital role in ensuring compliance with regulatory requirements for our clients.Key ResponsibilitiesDevelop and implement submission strategies for post-approval CMC activities, including variations,...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Parexel. As a key member of our regulatory team, you will play a vital role in ensuring compliance with regulatory requirements for our clients.Key ResponsibilitiesDevelop and implement submission strategies for post-approval CMC activities, including variations,...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    About the Role:We are seeking a highly experienced Senior Regulatory Affairs Consultant to join our team at Parexel. As a Senior Consultant, you will be responsible for leading internal projects on behalf of our clients, providing a broad range of consulting services, and working within project guidelines to identify, refine, and address client issues and to...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    About the Role:We are seeking a highly experienced Senior Regulatory Affairs Consultant to join our team at Parexel. As a Senior Consultant, you will be responsible for leading internal projects on behalf of our clients, providing a broad range of consulting services, and working within project guidelines to identify, refine, and address client issues and to...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly motivated and detail-oriented Quality Specialist (Regulatory Intelligence Specialist) to join our team.As a Quality Specialist, you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements relevant requirements.Key...


  • Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly motivated and detail-oriented Quality Specialist (Regulatory Intelligence Specialist) to join our team.As a Quality Specialist, you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements relevant requirements.Key...


  • Alcobendas, Madrid, España Kellanova A tiempo completo

    Join Kellanova at an exciting time for the team as we further our ambitions to become a snacking powerhouse. As a Regulatory Affairs Officer, you will be a valued member of the regulatory profession across the business and your experience, expertise and guidance will be essential in our existing and future growth. The role is full time based in our office in...

  • Senior RAQA Specialist

    hace 4 semanas


    Alcobendas, Madrid, España Stryker A tiempo completo

    Work Flexibility: HybridThe Job's MissionBased in Madrid, the Senior RAQA Specialist is responsible for implementing and improving Stryker's regulatory and post market surveillance system, the Quality Management system and the Environmental management system in Iberica.The focus is on ensuring the safety of health care professionals and patients that come...