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Quality and Regulatory Manager

InkSpace Imaging develops and manufactures next-generation MRI receive coils that dramatically
improve patient comfort and deliver superior image quality. Leveraging proprietary technology, advanced
materials, and user-centered medical-device design, we create ultra-lightweight, flexible coils that
contour to the body. These coils significantly improve scanning efficiency and workflow for technologists
and radiology teams, while elevating diagnostic performance across pediatric, adult, and specialty
applications. Our products are FDA-cleared and integrated with major OEM systems, bringing meaningful
impact to hospitals and imaging centers worldwide.


Join a fast-growing, mission-driven startup that is redefining the MRI experience for patients, clinicians,
and healthcare providers.


Quality & Regulatory Manager

Location: Pleasanton, CA 

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The Quality & Regulatory Manager will spearhead quality assurance and regulatory compliance efforts
for a fast-paced medical device startup. The position is central to securing MDR/CE marking in the EU,
sustaining lean manufacturing, implementing ISO 13485 with minimal disruption and bureaucracy, and
supporting entry into new global markets. This position will continue to support the FDA clearance of
devices in the US. The ideal candidate thrives in environments where hands-on work, agility, and
resourcefulness are valued. This is an on-site role and remote work is not available.

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Core Responsibilities

  • Lead the development, rollout, and ongoing refinement of the Quality Management System

  • (QMS), ensuring compliance with EU MDR 2017/745, MDSAP, and ISO 13485, building practical, lean processes appropriate for a small team.

  • Own the CE marking approval pathway, including compiling submissions, responding to requests from notified bodies, and maintaining needed technical documentation.

  • Oversee manufacturing quality, working hands-on with production teams to embed quality assurance and continuous improvement. Lead FMEA and NCMR.

  • Support the outsourcing of assemblies and develop supplier quality program to ensure zero defects.

  • Coordinate and deliver training to ensure all employees understand new QMS procedures and their compliance responsibilities.

  • Lead internal audits, manage non-conformances, and drive CAPA (Corrective and Preventive Action), emphasizing quick resolution and frequent incremental updates.

  • Maintain document control, ensuring quality and regulatory documentation is accurate, current, and audit-ready, ideally using pragmatic digital or paper-based systems.

  • Support product launches and ongoing compliance in new country markets, adapting regulatory  strategies and submitting required dossiers for each region.

  • Monitor regulatory changes, update relevant policies, and advise management and technical teams on regulatory strategies, market access, and post-market surveillance activities.

  • Act as the primary liaison with external regulatory authorities, notified bodies, and auditors.

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Qualifications

  • Bachelor’s degree in engineering, life sciences, or a related field; advanced degree preferred.

  • 10+ years experience in medical device quality assurance, ideally gained in a startup or small company.

  • Deep familiarity with EU Medical Device Regulation and ISO 13485 – hands-on experience with CE marking and 21CFR 820 is required.

  • Demonstrated ability to build and manage practical, lean quality systems that scale.

  • Strong communication, training, and cross-functional leadership skills.

  •  Comfortable managing change in a dynamic, resource-constrained environment.

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InkSpace Imaging offers a collaborative work environment, opportunities for professional growth, and a
competitive compensation package including stock options. The base pay range for this role is $110,000
to $145,000, and the final offer will depend on your skills, qualifications, and relevant experience.


InkSpace Imaging is an Equal Opportunity Employer. All employment decisions are made without regard
to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression,
age, disability, protected veteran status, or any other characteristic protected by applicable law.


InkSpace Imaging hires only individuals legally authorized to work in the United States. Employment is
contingent upon successful completion of a drug screen, verification of past employment, and any other
applicable background or compliance checks required for the position. Unless expressly stated, relocation
assistance is not available.

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