Rapidly growing leader in the ophthalmic market, with a core focus of NPD, innovation and technology application. QA/RA Technical File Specialist.
Rapidly growing leader in the ophthalmic market, with a core focus of NPD, innovation and technology application. Extensive portfolio across vast therapeutic classes.
- Remote Role - South based sites should you prefer to travel
- Key role within a global QARA function
- Strong progression opportunities, supportive team, exceptional benefits
- Improvement and maintenance of QMS, in line with ISO 13485, GMP, GDP and QRM to support wholesale 13485, MDR and MDD licenses
- Ensure all QA documentation, and processes are implemented and followed
- Participate in ISO/MDD/MDR regulatory inspections as a co-host and ensure any findings and related action plans in relation to the technical files are followed through completion
- Ensure investigations into deviations and the change requests impacting on the technical files are completed correctly and on time
- Ensure change management process is implemented in accordance with the site procedures and regulatory requirements and changes related to technical files documentation and processes are evaluated
- Participate as key stake holder in the management review process and ensure all supporting data is provided to the team and the assigned actions are completed on time.
- Participate in the self-inspection program and support in own area the internal audits, ensure the relevant actions are completed in an effective and timely manner, where related to technical files, by the relevant owners.
- Actively participate to ensure governance on data integrity, observe and ensure data integrity is continuously maintained and adequately controlled on site.
- Ensure the QMS documentation related to technical files is stored and archived following the relevant regulatory requirements and the quality documentation control process is effective and efficient.
- Ensure technical files for medical devices are issued, controlled, maintained and kept up to date with the current regulatory requirements
- Up to date knowledge of current regulatory requirements and own knowledge to enable the discharge of the relevant role duties
- Good technical knowledge of Medical device class IIA, regulations and guidelines
- Experienced in the management and maintenance of ISO 13485 regulatory approved QMS
- Highly collaborative, regular interaction with the internal team members, stakeholders, suppliers, customers and regulators.
- Experience in designing and maintaining technical files for medical devices in compliance with the MDD/MDR
- Minimum a BCS degree in life science.
- Experience in a similar Quality Assurance role within the medical device and Pharmaceutical Industry.
- Relevant ISO 13485/ MDD/MDR/GMP/GDP training as required to discharge assigned duties and responsibilities.
- Excel spreadsheets and EDMS operating skills
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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