Medical Device QA/RA Specialist

General Information

Location:         Bath and Remote

Contract:         Full time

Salary:            £40-43k. + relocation package

Role Information

We are looking for a QA/RA specialist with 3 to 5 years of experience in handling medical device quality and regulatory affairs from product design to market and beyond.

You will contribute to the development of new products, drive improvements in the company’s standards and maintain regulatory accreditations. You must have a passion and deep understanding of QMS culture in the MedTech industry. Your role will be vital to driving the company forward throughout new products and markets expansion (US and Canada).

This is a long-term opportunity for which we are keen to meet a smart and exceptionally talented individual with creativity in approaching problems or tasks; your enthusiasm and drive should enable you to become part of the fabric of our dynamic company and help you further your individual strengths for team success.

We’re growing fast and have a busy schedule to complete with rewarding plans for you.

Candidates must live or relocate nearby Bath or within short commutable distance.

3D-MP is a MedTech company delivering leading-edge healthcare solutions. Our mission is to restore and maintain patients’ quality of life using custom-made treatments with an innovative range of medical devices in additive manufacturing (including our unique TOKA® system) and digital solutions such as 3D surgical planning and Virtual Reality surgery. Our pioneering bespoke precision engineered surgical kit- TOKA® comprises a personalised (class 2b) implantable device and a mix of CE marked and custom-made surgical instrumentation. Therefore, a clear understanding of manufacturing process control in both areas is essential; specific knowledge in AM process is desirable.

The ideal candidate will also have experience / knowledge in SaMD validation and familiarity with software regulations in line with new MDR and relevant standards.

Qualifications

• Bachelor’s degree with scientific, engineering, regulatory, quality or legal core competency
• 3+ years’ experience in QA/RA role in surgical devices and MedTech product quality validation
• In-depth knowledge of ISO:13485, ISO:14971, CE marking, MDR, FDA 510(k)
• Excellent PC skills, including QMS software applications.
• Organisational skills and problem-solving approach
• Strong written communication skills: plans, procedures, work instructions and reports

Desirable:

• Experience in Software validation IEC:62304 and SaMD process certification
• Bilingual or with good knowledge of a second language

Early deliverables

• Apply for and maintain approval of ISO, CE, MDR standards for our devices
• Internal /external audit, CAPA process
• Preparation for IEC approval of software components
• Capable of promoting a culture of best practice

About us

We believe in developing people’s skills and ambition by promoting personal and professional development.

We offer a benefits package that’s highly desirable, including flexible and remote working hours, 25+8 days holiday, private pension and company’s shares options.

If you aspire to make a difference in people’s everyday life, we would like to hear from you. Please apply now.