Regulatory Affairs Specialist

hace 3 semanas

Barcelona, Barcelona, España Sinclair EBD A tiempo completo

Job Details: We are seeking a highly skilled Pre-Market Regulatory Affairs Engineer to join our Corporate Regulatory Affairs Team at Sinclair EBD. The successful candidate will be responsible for ensuring regulatory requirements are met for new product development and design changes to established legacy devices.

The Role: As a Pre-Market Regulatory Affairs Engineer, you will work closely with Research and Development and other business departments to ensure the design and development processes contain the correct regulatory requirements and supporting evidence. You will also be responsible for preparing technical documentation and submission packages for the filing of premarket global regulatory submissions.

Key Responsibilities:

  • Provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices, particularly in UE, EEUU and Canada territories.
  • Establish and maintain regulatory information systems, technical documentation files and routine reports.
  • Collaborate with global Regulatory Affairs teams to understand existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures.
  • Ensure regulatory compliance to global requirements and company policies.
  • Support new product development activities.
  • Review documents and product changes for regulatory submission impact.
  • Provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities.

Requirements:

  • Minimum 5 years experience in Regulatory Affairs (Pre-Market) within a Medical Device and 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.

What We Offer:

  • Competitive fixed salary aligned with the market + variable.
  • Medical + Dental Insurance.
  • Hybrid work model.
  • Flexible schedule + short Friday.
  • Fruit at the office.

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