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Direct message the job poster from Cure Talent Connecting the best talent in QARA with Innovative MedTech & STEM Organisations
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 as a part of an established team of Regulatory and Quality professionals. You will be involved in Technical File creation, maintenance & development, Product Registrations, Post Market Surveillance, Customer Complaints and CAPA reporting. 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 in the Medical Device industry. Proven experience & knowledge of interpreting and applying Medical Device standards and regulations. Experience in the authoring and/or maintenance of Technical Files under MDR. Familiarity with electro/mechanical products, along with an awareness of regulatory implications (highly desirable). Highly desirable experience with medical standards, as well as European and FDA regulations, including ISO 13485, ISO 14971, IEC 60601 and MDR. 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. Seniority level
Associate Employment type
Full-time Job function
Quality Assurance, Legal, and Engineering Industries
Medical Equipment Manufacturing
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Direct message the job poster from Cure Talent Connecting the best talent in QARA with Innovative MedTech & STEM Organisations
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 as a part of an established team of Regulatory and Quality professionals. You will be involved in Technical File creation, maintenance & development, Product Registrations, Post Market Surveillance, Customer Complaints and CAPA reporting. 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 in the Medical Device industry. Proven experience & knowledge of interpreting and applying Medical Device standards and regulations. Experience in the authoring and/or maintenance of Technical Files under MDR. Familiarity with electro/mechanical products, along with an awareness of regulatory implications (highly desirable). Highly desirable experience with medical standards, as well as European and FDA regulations, including ISO 13485, ISO 14971, IEC 60601 and MDR. 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. Seniority level
Associate Employment type
Full-time Job function
Quality Assurance, Legal, and Engineering Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
