QARA Manager – Medical Devices (ISO 13485, EU MDR)

Jago Consultants; Bracknell; On-site; GBP 54,000 - 66,000; Full time

Benefits offered by this job

Pension scheme

Dental plan

Bonus eligibility

Job summary

Jago Consultants is seeking a Quality Assurance and Regulatory Affairs Manager (QARA) in the Bracknell area to oversee the site Quality System, regulatory compliance, and product quality. You'll report to UK Operations Director and collaborate with US QA/RA teams to ensure robust processes and timely regulatory actions.

The role involves CAPA leadership, audits, and liaison with MHRA and Notified Bodies. Travel up to 15% may be required.

Qualifications

• Significant experience in quality or regulatory roles within medical devices.
• Deep understanding of medical device QMS and regulatory requirements (ISO 13485).
• Experience with Notified Bodies/audits is a plus.

Responsibilities

• Ensure compliance with Quality System and ISO 13485, EU MDR/MDD requirements.
• Lead internal and external audits including Notified Body audits.
• Own CAPAs and drive timely resolution of observations and non-conformities.
• Collaborate with US QA/RA teams to align processes at the UK site.
• Support field actions and regulatory communications with MHRA.

Skills

Quality management

Regulatory affairs

Medical devices

Audit coordination

CAPA leadership

Communication

Education

Bachelor's degree or equivalent

Job description

Jago Consultants is seeking a Quality Assurance and Regulatory Affairs Manager (QARA) in the Bracknell area to oversee the site Quality System, regulatory compliance, and product quality. You'll report to UK Operations Director and collaborate with US QA/RA teams to ensure robust processes and timely regulatory actions.

The role involves CAPA leadership, audits, and liaison with MHRA and Notified Bodies. Travel up to 15% may be required.