MedTech QA/Regulatory Associate β€” ISO 13485 & FDA Prep in Manchester

MedTech QA/Regulatory Associate β€” ISO 13485 & FDA Prep in Manchester

Manchester Full-Time 30000 - 37000 Β£ / year (est.) Hybrid
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At a Glance

  • Tasks: Support quality management systems and regulatory activities for ISO 13485 and FDA prep.
  • Company: Join ScubaTx Limited, a forward-thinking MedTech company in Manchester.
  • Benefits: Flexible working arrangements and opportunities for career growth.
  • Other info: Collaborate with external consultants and internal teams in a dynamic environment.
  • Why this job: Make a real impact in the MedTech industry while developing your skills.
  • Qualifications: Ideal for junior to mid-level candidates with a passion for quality and regulation.

The predicted salary is between 30000 - 37000 Β£ per year.

ScubaTx Limited is seeking a hands-on Quality & Regulatory Associate to support the execution of our QMS and regulatory activities as we progress ISO 13485 readiness and FDA 510(k) preparation. This role is execution-focused, supporting external QA/RA consultants and internal teams to ensure documentation, design controls and quality processes are implemented accurately and on time.

This is a junior–mid level position with flexible working arrangements in Manchester and opportunities to grow.

MedTech QA/Regulatory Associate β€” ISO 13485 & FDA Prep in Manchester employer: ScubaTx Limited

ScubaTx is an exceptional employer, offering a dynamic work environment at the forefront of medical technology innovation in Manchester. With a strong emphasis on employee growth and development, team members are encouraged to engage in meaningful projects that directly impact patient care, while enjoying the unique opportunity to collaborate with leading clinicians in both the UK and the USA. The company's commitment to fostering a supportive culture, alongside competitive benefits and the chance to be part of groundbreaking advancements in organ preservation, makes it an attractive place for passionate professionals seeking rewarding careers.

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Contact Details:

ScubaTx Limited Recruitment Team

We think you need these skills to ace MedTech QA/Regulatory Associate β€” ISO 13485 & FDA Prep in Manchester

Quality Management System (QMS)
ISO 13485
FDA 510(k) Preparation
Documentation Management
Design Controls
Quality Processes Implementation
Execution Focus