1. Job purpose
The purpose of the Regulatory Affairs and Quality Assurance Associate is to support the Regulatory and Quality department in the maintenance, management and development of the Company’s quality management system ensuring product and procedural compliance to ISO13485: 2016, FDA and EU MDR Regulatory requirements.
2. Duties and responsibilities
Ensure compliance throughout the document/record lifecycle: including the creation, approval, issuance, revision, retention, timely retrieval during audits, and obsoletion.
Provide oversight of the document periodic review program and ensure status is conveyed to internal stakeholders.
Support Document Control and Change Management by tracking requested revisions and ensuring internal teams are apprised of changes and that implementation dates are met.
Proactively identify opportunities for process improvements, automation, and efficiency gains in the document control function.
Update and maintain complete and accurate regulatory compliance records including Non-conformances (NCs), Corrective & Preventative Actions (CAPA).
Update and maintain complete and accurate Quality Management System and Health and Safety Employee and New Hire Training requirements.
Maintain organized files for all regulatory documents and data.
Assist with Clinical Investigation submissions
Provide support on other RA/QA projects when necessary
Perform other duties as assigned
3. Qualifications
~ Bachelor’s Degree required; life science or related field, preferred
~ Experience with document control management systems, Greenlight Guru experience preferred.
~ Strong foundational knowledge in Good Documentation Practice (GDP) per ISO13485: 2016
~ Knowledge of current Good Clinical Practice (cGMP) for Medical Devices per ISO14155: 2020
~2+ years of relevant experience in document control/record control (including standard process creation and implementation); biotech, pharma, drug product, or medical device document control experience preferred
4. Working conditions
The job does not require the person to work in special working conditions.
5. Physical requirements
The job is not physically demanding and does not have any no specific physical requirements.
Salary Range; £30,000-£36,000 depending on experience