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Regulatory Affairs Specialist – Medical Devices
hace 1 mes
Regulatory Affairs Specialist – Medical Devices, BarcelonaLocation:Barcelona, SpainJob Category:Engineering, Healthcare, ScienceEU work permit required:YesJob Views:8Posted:20.01.2025Expiry Date:27.01.2025Job Description:General AccountabilityResponsible for regulatory affairs activities to build the QMS, and participate in regulatory submission, annual reports, registrations, and listings.
Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards.
Creation and maintenance of all regulatory files.What we expectYou guarantee that the regulatory requirements regarding (inter)national regulation and international standards are met.You will be responsible for the development and maintenance of the QMS systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.You keep track of the ever-changing regulations in all the regions (starting with Europe) in which a company wishes to distribute its products and evaluate the impact on the business.You advise on the regulatory and scientific restraints and requirements while collecting and evaluating scientific and medical data.You supervise the exchange and presentation of the registration documents to the Notification Body or competent authority.You work with international, national, and local regulatory agencies.You train people on medical device regulation and all its related aspects such as submission procedures.You offer support during product launch: reviewing marketing materials, and product registration.
After launch, you are involved in post-market surveillance tasks and handling of adverse events.What you will bringYou have a master's degree in a scientific discipline and 2-4 years of experience in regulatory affairs related to medical devices, meeting the requirements of MDR to serve as a PRRC (Person Responsible for Regulatory Compliance), including holding a relevant degree and one year of experience or four years of experience working with quality standards in the medical device field.You have knowledge of regulations for Medical Devices (21 CFR 820 & EU MDR, 510(k)), quality management systems (ISO 13485, ISO 27001), technical standards applicable to medical devices, and software used for Medical Devices (IEC 62304).You have knowledge of the relevant national and international legislation, procedural regulations, and technical regulations.You feel comfortable taking care of the early-stage considerations and the development of regulatory plans.Please attach your CV in EnglishEmployment Type:Full time, Remote Work
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