Medical Device Regulatory Compliance Expert

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €50,000 - €65,000

**Job Overview**

We are seeking an experienced Regulatory Affairs Specialist to join our team. This role will play a key part in the development of our regulatory strategy and ensure compliance with relevant regulations.

**Key Responsibilities**

  • Support the creation and maintenance of product design and technical documentation in compliance with relevant regulations and standards.
  • Develop and submit high-quality clinical and regulatory files to ethical committees and regulatory agencies.
  • Organise and maintain regulatory and clinical submissions with regulatory authorities, ethical committees, and clinical investigation sites.
  • Co-ordinate and conduct gap assessment activities in line with updated regulatory requirements and standards.
  • Keep up-to-date with changes in applicable regulatory requirements and standards.
  • Assist company preparation for inspection by notified body and regulatory authorities.
  • Support implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485, including risk management.
  • Continuous improvement of the Quality Management System to meet the requirements of all stakeholders.
  • Coordinate and progress Adverse Event reporting to regulatory authorities as required by QA/RA Director.

**Requirements**

  • Bachelor degree in science, engineering or related field.
  • Proven track record in a similar role with a minimum of 5 years in medical device Regulatory Affairs.
  • Extensive knowledge of quality management systems, design controls per ISO 13485 and current International and European regulations/standards with respect to medical devices.
  • In-depth knowledge of the EU Medical Device Directive and MEDDEV guidance documents.
  • Experience in design, verification and process validation processes.
  • Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems.

**Benefits**

  • Excellent opportunity to work in a dynamic and growing industry.
  • Chance to develop your skills and expertise in regulatory affairs.
  • Opportunity to work on a range of projects and contribute to the success of the organisation.

**Additional Information**

If you are interested in this role, please contact us to discuss further details.

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