Quality Systems Specialist β€” Medical Devices & Regulatory

Quality Systems Specialist β€” Medical Devices & Regulatory

Full-Time 42750 - 52250 Β£ / year (est.) No working from home possible
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At a Glance

  • Tasks: Maintain quality management systems and conduct product compliance reviews.
  • Company: Mira, a leading player in the medical devices sector.
  • Benefits: Remote work, competitive salary, and opportunities for professional growth.
  • Other info: Collaborate with global teams and support crucial audits.
  • Why this job: Join a dynamic team and make a difference in healthcare innovation.
  • Qualifications: Experience with ISO 13485 and medical device regulations required.

The predicted salary is between 42750 - 52250 Β£ per year.

Mira in the US is seeking a Quality Systems Specialist to maintain the QMS, conduct product compliance reviews, and train staff on SOPs.

This remote role collaborates with R&D and regulatory teams across time zones.

You will support audits (FDA, ISO, MDSAP), manage CAPA and document control, and help ensure timely regulatory submissions.

A strong background in ISO 13485 and medical device regulations is essential.

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Quality Systems Specialist β€” Medical Devices & Regulatory employer: Mira

Mira is an exceptional employer that prioritises employee growth and well-being, offering a flexible remote work environment that allows for a healthy work-life balance. With a strong focus on professional development and a commitment to innovative healthcare solutions, employees are empowered to make a meaningful impact in women's health while collaborating with a passionate team in the vibrant San Francisco area.

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Contact Details:

Mira Recruitment Team

We think you need these skills to ace Quality Systems Specialist β€” Medical Devices & Regulatory

Quality Management Systems (QMS)
ISO 13485
Regulatory Compliance
SOP Training
Audit Support
CAPA Management
Document Control