Regulatory Affairs Specialist

hace 6 días

Barcelona, Barcelona, España Empresa reconocida A tiempo completo

Are you looking for a challenging role within a renowned company's Regulatory department? This is your opportunity to join Empresa reconocida as a Regulatory Affairs Specialist at their Barcelona office for the Energy Devices division.

The Role:

Working within the Regulatory Affairs Team, the Junior Regulatory Affairs Specialist assures regulatory requirements are met for new product development and design changes to established legacy devices. Reporting to the Team Leader Registration & RA Engineer, the position holder assures the design and development processes contain the correct regulatory requirements and supporting evidence. Working closely with Research and Development and other business departments, the position holder will also ensure the type testing certification such as electrical compatibility and compliance to product specific standards and directives are in place. This assures the integrity of the design history file and technical documentation as a precursor to country specific registration(s).

This position provides and contributes to the Regulatory deliverables from internal Research and Development projects, contributes to providing Regulatory solutions to business requirements and changes to the regulatory landscape. This position provides operational Regulatory support to cross-functional teams, ensuring compliance to the UK, European and International country specific legislations.

Responsibilities:

  1. Preparation of technical documentation and submission packages (STEDs) for the filing of premarket global regulatory submissions in line with company strategy.
  2. Establish and maintain regulatory information systems, technical documentation files and routine reports.
  3. 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.
  4. Ensure regulatory compliance to global requirements and company policies.
  5. Support new product development activities.
  6. Review documents and product changes for regulatory submission impact.
  7. Liaise with and assist the vigilance team with respect to requirements of product dossiers and relevant post marketing activities as and where necessary.
  8. Assist and support inspections and audits.

Valuable Qualifications:

  1. 1 year' experience in Regulatory Affairs within a Medical Device or Aesthetics organisation.
  2. Working knowledge of the Medical Device Regulation and Medical Device Directive.
  3. Excellent attention to detail when reviewing and preparing documentation.
  4. Organised, target-oriented, flexible, with good time management skills.
  5. Strong written and oral communication skills.
  6. Fluency in written and spoken English.

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