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Details
Senior Regulatory Affairs Specialist
Reference: | JCAO3103 | Location: |
Dublin |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Regulatory Affairs, Senior Regulatory Affairs Officer
Our client a medical device start up are looking for a Senior Regulatory Affairs Specialist to support the product development of a cutting-edge device through design development, verification, clinical trials, validation and regulatory approvals. This position can be fully remote.
Role/Responsibilities
- Provide regulatory guidance to product development team, working closely with cross-functional team members to develop and implement the regulatory strategy.
- Lead the development, submission and maintenance of high quality clinical and regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval.
- Support the creation and maintenance of product design and technical documentation in compliance with the relevant regulations and standards (Class III, animal derived, implantable devices).
- Assess and support design and process changes with cross-functional team members, ensuring completion of all associated regulatory activities.
- Keep up to date with changes in applicable regulatory requirements and standards, and where appropriate coordinate and/or conduct gap assessment activities.
- Participate in discussions with regulatory authorities.
- Assist company preparation for inspection by notified body and regulatory authorities.
- Support implementation and continuous improvement of a robust and fully compliant quality system in accordance with ISO 13485, including risk management.
- Administrate the processes for the control of product information, including labelling, Instructions For Use (IFU), and user training.
- Ensure interactions with colleagues/stakeholders fully reflects the company values:
- One Team: working together to ensure the whole is greater than the sum of the parts
- Personal Ownership: deliver on commitments
- Open Communication: Honest open-minded communication
- Fun: celebrate the successes
- Continuous Learning: at an individual and company level
- Solution Orientated: Identify problems but focus your energy on solutions
- Quality Focused: patient safety comes first
- Bachelor’s or master’s degree in science or related disciplines
- Minimum of five (5) years of related experience in Regulatory Affairs
- Experience preparing technical documentation for submission to regulatory agencies
- Class III medical device experience preferred
- Clinical trial experience preferred
- Working knowledge of GMP, FDA QSR and ISO 13485 requirements
- Excellent communication, organisational and time management skills
- Availability to travel is required
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