Senior QA/RA Specialist - Remote & Impactful Compliance

ResMed; Shefford; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A medical device company is seeking a Senior QA/RA Specialist for Quality Assurance. This role entails ensuring compliance with management systems and regulatory frameworks, coordinating quality activities, and managing regulatory submissions. Candidates should have a Bachelor's degree and experience in regulatory affairs related to medical devices. The position offers a supportive and dynamic work environment, along with a bonus plan and work from home flexibility.

Benefits

Bonus plan based on position

Work from home flexibility

Referral bonus

Preferred shareholding programme

Qualifications

• At least one year of experience in regulatory affairs or quality management systems for medical devices.
• Strong experience in Quality Systems and Medical Device Regulation (MDR 2017/745).

Responsibilities

• Ensure compliance with quality management systems and regulatory frameworks.
• Coordinate complaint handling and investigations.
• Support design quality rigor and oversee product quality.
• Manage regulatory submissions and maintain regulatory records.

Skills

Knowledge of ISO 13485

Communication skills

Organizational skills

Teamwork building

Attention to detail

Education

Bachelor's degree in a technical or software field

Job description

A medical device company is seeking a Senior QA/RA Specialist for Quality Assurance. This role entails ensuring compliance with management systems and regulatory frameworks, coordinating quality activities, and managing regulatory submissions. Candidates should have a Bachelor's degree and experience in regulatory affairs related to medical devices. The position offers a supportive and dynamic work environment, along with a bonus plan and work from home flexibility.