LOCATION
Irvine, CA
TECHNOLOGY
Venous Thrombectomy
COMPANY HQ
Irvine, CA
COMPANY SIZE
1000+ Employees
POSITIONOVERVIEW
Inari Medical is the global leader in venous clot removal having developed three thrombectomy technology platforms for the treatment of venous thrombosis. Funded by prestigious venture capital firms, Gilde Healthcare, Versant Ventures, and U.S. Venture Partners, Inari debuted as the Best U.S. IPO of 2020 and generated $235M in revenue in 1H 2023 with a 31% increase from 2022. Oh, and Inari Medical is named after a piece of sushi…inari sushi. Inari is hiring their Sr. Principal, Quality Compliance Engineer.
- Press: Inari in the News
- Revenue: Inari Q2 2023 Financials
- ClotTriever: The ClotTriever System
- FlowTriever: FlowTriever Retrieval/Aspiration System
We have partnered with Bertha Flores Sr. Director of Quality Assurance and Engineering, to hire our Sr. Principal, Quality Compliance Engineer. This position will be own product sustainment and compliance activities while building out the product compliance function in Inari Medical. The Quality Compliance function will own GAP assessments and GAP analysis processes, understand OUR regulations related to product compliance, and own the compliance processes interpreting the remediations and testing.
POSITIONDETAILS
- Identify applicable new or revised global regulatory requirements and standards relevant to Inari products and Quality Management System (QMS)
- Provide expertise and guidance in interpreting applicable global regulatory requirements and standards to assure compliance
- Complete detailed assessments of new or revised regulations and applicable standards (standard-to-standard gap analysis)
- Perform impact evaluation of said changes on existing products and QMS
- Create action plans to ensure products and QMS remain in compliance
- Lead efforts with cross-functional partners to execute action plan(s)
- Ensure that activities are performed and documented per company policies and procedures intended to assure the effectiveness and safety of our products
- Provide constructive evaluation of procedures, test protocols and reports intended to provide evidence of conformity
- Monitor compliance of company policies and procedures with regulatory requirements and standards (e.g. compliance with FDA, MDSAP, EMEA, APAC and emerging market regulations and standards etc)
- Demonstrate appropriate risk-based decision making, and prioritize key activities to maintain product conformity and QMS compliance
- Support internal and external audits as Subject Matter Expert for sustaining state of the art conformity during the product lifecycle and QMS
- Perform other duties as assigned.
- Bachelor’s Degree in a Technical or Engineering discipline required.
- Related work experience with a strong understanding of Compliance
- Experience in the medical device or healthcare related industries
- Broad knowledge of global regulations and standards
- Strong knowledge of Compliance as it relates to Design Controls, Risk Management, and Quality Management Systems
- Manage competing priorities in a fast-paced and dynamic environment
- Work in cross-functional team environment
- Strong problem-solving, organizational, analytical, and critical thinking skills
- Excellent, proven interpersonal, verbal and written communication skills
- Must be living in, or willing to relocate to, Irvine, CA.
COMPANYOVERVIEW
Inari Medical, Inc. is a publicly traded medical device company dedicated to the development of innovative catheter-based technologies for the treatment of venous thromboembolism. Inari is focused on solutions that enable the safe removal of large clot volumes from big vessels without the use of thrombolytic drugs. Inari has developed three novel mechanical thrombectomy technology platforms.
The FlowTriever System has FDA clearance for the treatment of pulmonary embolism and for thrombectomy in the peripheral vessels. The ClotTriever System has FDA clearance for thrombectomy in the peripheral vessels. The InThrill System has FDA clearance for small vein and AV thrombectomy. Inari was founded in 2013 as a spin-out of Inceptus Medical, a medical device incubator.
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Company Overview
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Compliance Engineer
Irvine, CA
PRESENTED BY
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