This role is accountable for building, maintaining, and continuously improving a Quality Management System that meets global medical device regulatory requirements. As a Senior Specialist, you will guide QMS development and execution across the organization, ensuring regulatory readiness, audit compliance, and alignment with corporate quality standards.
Ensure Quality Management System (QMS) compliance with applicable internal and external regulatory requirements, including site, corporate, FDA, ISO, EU MDR, and country‑specific regulations.
Develop, implement, and control updates to regional and local quality management system processes aligned with corporate and divisional QMS requirements.
Support the management and coordination of internal and external audits, including preparation, execution, and follow‑up activities.
Coordinate and lead Management Review forums in accordance with applicable procedures, including preparation of meeting minutes and follow‑up action items to closure.
Participate in the development, maintenance, and continuous improvement of quality policies and procedures.
Review and approve quality compliance documentation, including non‑conformances, corrective and preventive actions, and change controls, as required.
Manage document control activities, including routing, release, distribution, archiving, and retrieval to ensure current documentation is available as required.
Coordinate regulatory correspondence and additional information requests from health authorities and customers, including notifications to corporate regulatory and quality teams.
Required
Bachelor’s degree in engineering, science, or business administration.
Minimum 4 years of regulatory or quality systems experience within the medical device industry or another FDA‑regulated manufacturing environment.
Prior experience working in a legal, technical, or regulatory environment.
Proficiency in English and Spanish (written and verbal, business level).
MS Office knowledge
Preferred
Quality or regulatory certification (e.g., Certified Quality Auditor, Certified Quality Engineer, Six Sigma).
Certified Lead Auditor for ISO 13485:2016.
Experience working with electronic quality or document management systems.
Skills Required
- Bachelor's degree in engineering, science, or business administration.
- Minimum 4 years of regulatory or quality systems experience in the medical device industry or FDA-regulated environment.
- Prior experience working in a legal, technical, or regulatory environment.
- Proficiency in English and Spanish (written and verbal, business level).
- MS Office knowledge
- Quality or regulatory certification (e.g., Certified Quality Auditor, Certified Quality Engineer, Six Sigma).
- Certified Lead Auditor for ISO 13485:2016.
- Experience working with electronic quality or document management systems.
Inari Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.
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Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
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Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
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Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.
Inari Medical Insights
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
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