Senior QA/RA Specialist - Remote & Impactful Compliance

ResMed; Harrogate; On-site; GBP 45,000 - 60,000; Full time

Job summary

A healthcare technology company is seeking a Senior QA/RA Specialist to join their Quality Assurance team. The role involves ensuring compliance with quality management systems and regulatory frameworks for medical devices. Responsibilities include coordinating QMS activities, defining regulatory strategies, and collaborating with global teams to maintain high standards. Candidates should possess a relevant Bachelor's degree and significant experience in quality systems and regulatory affairs. This position offers competitive benefits, including work-from-home flexibility.

Benefits

Bonus plan

Flexibility to work from home

Referral bonus

Preferred shareholding programme

Qualifications

• Bachelor's degree with at least 1 year in regulatory affairs or quality management for medical devices.
• Strong experience in Quality Systems and Medical Device Regulation (MDR 2017/745).

Responsibilities

• Ensure effective Quality Management System processes are defined and maintained.
• Coordinate QMS activities including complaint handling and audits.
• Define regulatory strategies and timelines for submissions.

Skills

Knowledge of ISO 13485

Quality Management Systems

Communication skills

Organizational skills

Proactive initiative

Education

Bachelor's degree (technical or software background preferred)

Job description

A healthcare technology company is seeking a Senior QA/RA Specialist to join their Quality Assurance team. The role involves ensuring compliance with quality management systems and regulatory frameworks for medical devices. Responsibilities include coordinating QMS activities, defining regulatory strategies, and collaborating with global teams to maintain high standards. Candidates should possess a relevant Bachelor's degree and significant experience in quality systems and regulatory affairs. This position offers competitive benefits, including work-from-home flexibility.