LOCATION
Irvine, CA (hybrid)
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 Quality Engineer and Product Compliance Lead and a Global 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 Quality Engineer and Product Compliance Lead and a Global Quality Compliance Engineer. These positions will be own product sustainment and compliance activities while building out the product compliance function in Inari Medical. Our Global Compliance Lead will partake in GAP assessments, understand remediations, and support global compliance efforts.
POSITIONDETAILS
- Carry out managerial responsibilities in accordance with company policies and applicable laws.
- Provide leadership, oversight, and accountability in the development and implementation of broad-scale compliance initiatives
- Develop and executes a comprehensive global product compliance strategy aligned with the company’s business objectives and values.
- Stay up to date with relevant international regulations, standards, and industry best practices to ensure our compliance practices remain current and effective.
- Lead efforts to identify, interpret and assess global compliance regulations and standards, including but not limited to safety, quality, labeling, biocompatibility, environmental and sterilization regulations.
- Implement processes to actively monitor and track changes in regulations and standards, and effectively communicate those changes to internal stakeholders.
- Collaborate with cross-functional teams to integrate compliance requirements throughout the product lifecycle and Quality Management System.
- Share knowledge and collaborate on a wide range of competing business priorities and tailor risk-based compliance solutions accordingly.
- Develop and deliver training programs to educate internal teams on product compliance obligations and best practices. Network with external stakeholders, such as regulatory authorities, industry associations, and certification bodies to stay informed on regulatory changes.
- Foster a culture of proactive compliance and accountability within the team and across the organization.
- Other duties as assigned.
- Bachelor’s Degree in a Technical or Engineering discipline required.
- Strong leadership and critical thinking skills.
- Excellent communication and presentation skills with the ability to influence stakeholders at all levels of the organization.
- Detail oriented, analytical, and able to work collaboratively with cross-functional teams in a fast-paced, dynamic environment.
- Experience in product compliance management within the medical device industry.
- Strong knowledge of international product compliance regulations and standards.
- 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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Manager, Global Product Compliance
Irvine, CA
PRESENTED BY
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