Regulatory Affairs Specialist

hace 5 días

Barcelona, Barcelona, España Com si fos ahir A tiempo completo

Job Overview


We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Com si fos ahir. The successful candidate will be responsible for ensuring regulatory compliance and ensuring that our medical devices meet the highest standards.



About the Role


The Regulatory Affairs Specialist will be responsible for providing expert knowledge and guidance on regulatory legislation and guidelines for medical devices. This includes preparing technical documentation and submission packages for global regulatory submissions, establishing and maintaining regulatory information systems, and collaborating with global Regulatory Affairs teams.



Responsibilities



  • Provide expert knowledge and guidance on regulatory legislation and guidelines for medical devices
  • Prepare technical documentation and submission packages for global regulatory submissions
  • Establish and maintain regulatory information systems
  • Collaborate with global Regulatory Affairs teams
  • Ensure regulatory compliance and ensure that medical devices meet the highest standards
  • Review documents and product changes for regulatory submission impact
  • Provide relevant regulatory advice and guidance to assist other personnel in the performance of their roles and responsibilities
  • Review and approve product artworks and marketing materials according to company strategies and applicable regulatory requirements or standards
  • Identify, deliver, and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs
  • Liaise with and assist vigilance team and risk management team with respect to requirements of product dossiers and relevant post-marketing activities as and where necessary
  • Assist and support inspections and audits
  • Liaise with, assist, and support in the creation of QMS process for regulatory aspects
  • Responsible for the local implementation and training of regulatory process
  • Responsible for leading and monitoring the assigned registration processes in countries of commercialization of the Company's medical devices
  • Coordinate and prepare documentation associated with registers of medical devices to be delivered to national or international Health Authorities
  • Administrative tasks and procedures in different embassies and consulates for legalization of documents necessary for registration of products in different countries
  • Coordinate signature of Quality and Release certificates of cosmetics and medical devices
  • Deputise for Manager as required


Requirements


To be successful in this role, you will need:




  • Minimum 5 years experience in Regulatory Affairs (Pre-Market) within a Medical Device company with active medical devices (energy devices)
  • Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC 62304)
  • Experience with the Medical Device Regulation
  • Knowledge of other regulatory legislation and guidelines, e.g., UE, EEUU, and Canada regulations
  • Excellent attention to detail when reviewing and preparing documentation
  • Organised, target-orientated, flexible, good time management skills
  • Strong written and oral communication skills
  • Fluency in written and spoken English
  • Ideally, experience with cybersecurity or AI


What We Offer


As a Regulatory Affairs Specialist, you can expect:




  • Competitive fixed salary aligned with the market + variable (£55,000 - £65,000)
  • Medical and Dental Insurance
  • Hybrid work model
  • Flexible schedule + short Friday
  • Fruit at the office
  • Enjoyable, dynamic, and international environment
  • Ongoing training and development opportunities
  • A chance to work on challenging projects and contribute to the growth and success of the company

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