Senior Regulatory Compliance Manager

1 day ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €65,000 - €95,000

Join a medical device start-up in an exciting early stage as a Senior Regulatory Affairs Specialist.

This is a unique opportunity to work on a Class III implant product and contribute to the Design History File.

About This Role:

We are seeking a highly experienced professional to take an active role in developing the regulatory strategy for Europe and the US, interacting with relevant regulatory bodies.

Your Key Responsibilities:
  • SUPPORT THE CREATION AND MAINTENANCE OF PRODUCT DESIGN AND TECHNICAL DOCUMENTATION, ensuring compliance with relevant regulations and standards (Class III, animal-derived, implantable devices).
  • DEVELOP AND SUBMIT HIGH-QUALITY CLINICAL AND REGULATORY FILES to ethical committees and regulatory agencies, ensuring successful approval.
  • ORGANISE AND MAINTAIN REGULATORY AND CLINICAL SUBMISSIONS with regulatory authorities, ethical committees, and clinical investigation sites.
  • COORDINATE GAP ASSESSMENT ACTIVITIES in line with updated regulatory requirements and standards.
  • STAY UP-TO-DATE WITH CHANGES IN APPLICABLE REGULATORY REQUIREMENTS.
  • ASSIST WITH PREPARATION FOR INSPECTION BY NOTIFIED BODIES AND REGULATORY AUTHORITIES.
  • SUPPORT IMPLEMENTATION AND MAINTENANCE OF A ROBUST QUALITY SYSTEM in accordance with ISO 13485, including risk management.
  • IMPROVE THE QUALITY MANAGEMENT SYSTEM TO MEET STAKEHOLDER REQUIREMENTS.
  • REPORT ADVERSE EVENTS TO REGULATORY AUTHORITIES as required by QA/RA Director.
  • MANAGE PRODUCT INFORMATION CONTROL PROCESSES, including labelling, Instructions For Use (IFU), and user training.
Requirements:
  • Bachelor's degree in science, engineering or related field.
  • Minimum 5 years of experience 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.
  • Prior experience in class III medical products highly preferred.
  • Prior experience in a medical device start-up preferred.
  • Good leadership and project management skills with ability and willingness to build and manage a small team.
  • Excellent verbal and written communication skills.

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