QARA Associate
Surrey – Hybrid (3 Days On-Site, 2 Days Remote)
Role Summary
GxPeople Global is seeking a QARA Associate to join a leading Medical Device company in Surrey. Our client is an Employee-Owned organisation, where every team member has a voice in shaping the company’s future.
This is a full-time hybrid position, offering a balance of on-site collaboration and remote flexibility.
Key Responsibilities:
1. Quality & Regulatory Compliance
o Contribute to the Quality and Regulatory Affairs department.
o Maintain ISO 13485 certification and ensure ongoing Quality Management System (QMS) compliance.
o Manage CE Marking certification, ensuring compliance with EU MDR regulations and handling audits from the Notified Body.
o Oversee international product registrations, including FDA (USA), Canada, Australia, and Brazil.
2. Audit & Risk Management
o Set up and execute internal audits as directed by Quality Management.
o Support on-site external audits, evaluate findings, and implement corrective actions.
3. Product Development & Compliance
o Participate in Product Development evaluation and planning.
o Maintain product modification records to ensure continued compliance.
o Work closely with suppliers to ensure regulatory adherence.
4. Training & Regulatory Updates
o Keep up to date with changing regulations and industry developments.
o Train internal teams on QA procedures—familiarity with Quality Assurance management software will be a distinct advantage.
Qualifications & Experience:
• Minimum 2 years of experience in Quality and/or Regulatory Affairs, ideally within the Medical Device industry.
• Technical degree preferred, with a strong foundation in biomedical sciences or related fields.
• Bachelor’s degree in a technical subject, such as Biology, Life Sciences, Electronic/Electrical Engineering, Physics, Mechanical Engineering, or Health Science.
• Experience working on technical documents under MDR is highly desirable.
What’s in It for You?
• Competitive salary + Employee Ownership company-wide monthly commission bonus.
• End-of-year profit share as part of Employee Ownership benefits.
• 31 days holiday, including Bank Holidays.
• Flexible working hours to support work-life balance.
• Personal and professional development training opportunities.
• On-site parking & Cycle to Work Scheme.
• Company pension scheme.
If you are a QARA professional looking to take the next step in your career with a company that values ownership, investment in development, and long-term growth, apply today or contact us for a confidential discussion.