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Cure Talent are excited to be working with a market leading MedTech manufacturer, specialising in innovative surgical products, based in the heart of the home counties. Due to their exceptional continued growth, we have a superb opportunity for a Regulatory Affairs Engineer to join the team,
As the new Regulatory Affairs Engineer, you will be working closely with the Head of QARA and as a part of an established team of Regulatory and Quality professionals. In your role will be responsible for the maintenance and development of technical files under MDR and will assist in the transition to MDR. You will be involved in Product Registrations, Post Market Surveillance, Customer Complaints and CAPA reporting.
To be successful as the new Regulatory Affairs Engineer we are looking for an experienced MedTech Regulatory Affairs professional with proven experience of the maintenance and development of Technical Files under MDR. Knowledge and experience of ISO 13485:2016 is essential for this role. Knowledge of IEC 60601 is highly advantageous.
RESPONSIBILITIES
- Work with internal departments and external regulators, suppliers and customers with a broad remit to ensure the ongoing product and systems compliance to the applicable regulations and standards.
- Assist in the maintenance and review of technical product files and assist in the continued transfer to the MDR.
- Work with the design department to ensure ongoing regulatory compliance of current and new products.
- Collaborate with a team of design engineers to produce a variety of technical documentation (such as risk assessments, test reports, etc).
- Work with internal departments, Competent Authorities, other national authorities and our Notified Body on product and company registrations.
- Assist in the actioning, monitoring and reviewing of NCRs, customer complaints, CAPA reports and return in warranty failures, assisting with the identification and implementation of corrective / preventative actions to continuously improve on these.
EXPERIENCE
- Proven Regulatory Affairs Experience within the Medical Device sector.
- Experience of interpreting and implementing standards and regulations essential.
- Broad background in quality and regulatory compliance of systems and products essential.
- Broad background in electro/mechanical products essential, along with an understanding of the impact of regulatory requirements.
- Experience of medical standards and European/ FDA regulations such as ISO 13485, EC 93/42 and MDR highly desirable.
- Experience of Cybersecurity, AI/ML, HFE, Usability, Software Development and/or Biocompatibility is highly advantageous
If you have the necessary skills and experience and want to join a company passionate about your progression, click apply now or contact Kris Holmes to discuss further.
