LOCATION
Irvine, CA
TECHNOLOGY
Venous Thrombectomy
COMPANY HQ
Irvine, CA
COMPANY SIZE
1000+ Employees
POSITIONOVERVIEW
Inari Medical is expanding its regulatory affairs team to pursue the OUS markets to remain the global leader in venous clot removal that has developed three thrombectomy technology platforms for the treatment of venous thrombosis. Inari Medical forecasts 40% of their growth to be tied to OUS expansion, which makes this growth effort a key focus for Inari’s executive management and the public markets. Oh, and Inari Medical is named after a piece of sushi…inari sushi.
Prior to Inari Medical’s successful IPO in 2020, Inari was funded by prestigious venture capital firms, Gilde Healthcare, Versant Ventures, and U.S. Venture Partners, and then debuted as the best U.S. IPO of 2020. This year, Inari generated $235M in revenue in 1H 2023 with a 31% increase from 2022. We are hiring our Senior Manager, International Regulatory Affairs Leader that will initially focus on EMEA and APAC market expansion.
- Press: Inari in the News
- Revenue: Inari Q2 2023 Financials
- ClotTriever: The ClotTriever System
- FlowTriever: FlowTriever Retrieval/Aspiration System
We have partnered with Keith Herbert, Senior Director of Regulatory Affairs, and Jayme Yamaguchi-Owens, Director of Regulatory Affairs, to hire our Senior Manager, International Regulatory Affairs. This position will lead a team of direct reports and support cross functional teams with submissions and additional regulatory documents for Class I, II, and III devices to international regulatory bodies.
POSITIONDETAILS
- Support development of regulatory strategy and preparation of submissions for Class I/II/III devices.
- Support multiple projects simultaneously, track timelines and establish contingency plans.
- Support review of Notified Body applications and other regulatory documents including Technical File / Design Dossier / STED submissions, and Change Notifications as assigned.
- Interact and liaise with local regulatory agency authorities for initial submission and follow up, local registrations and query resolution.
- Interact, liaise, and provide RA support to direct Inari personnel and Inari distributors in EU/OUS.
- Upload registrations and update registrations in EUDAMED.
- Support tender operations by timely supply of accurate regulatory documents.
- Support global advocacy efforts in monitoring regulation changes across regions.
- Complete the mandatory Quality training subject to the defined timeline and ensuring compliance with internal Quality system and policy.
- Suggest opportunities to add efficiencies to existing processes as part of RA department’s goals.
- Support complaint handling, post-market and vigilance reporting requirements, assist in field safety actions.
- Support RA functional area in the review and approval of Change Orders.
- Review and interpret local/regional regulatory rules as they relate to company products and procedures, testing or record-keeping and ensure that they are communicated to appropriate stakeholders.
- Follow changes of the EU/OUS regulatory landscape, identify impact to the company and support development of solutions to maintain regulatory compliance.
- Review promotional material and labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
- Bachelor’s degree in a scientific field (life sciences, engineering) is preferred.
- A minimum of 5 years’ experience in preparing international product submissions in a medical device company is required or 3 years with an advanced degree.
- Experience with the EU Medical Device Regulation 2017/745 and standards (ISO 13485, ISO 14971, etc.).
- Support multiple projects simultaneously.
- Detail oriented with well-developed writing and analytical skills.
- Excellent, proven interpersonal, verbal, and written communication skills.
- Interpret subjective and complex aspects of specific regulations, with thorough understanding of multiple sets and tiers of associated regulations.
- Ability to work autonomously with minimal direction.
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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International Regulatory Affairs Leader
Irvine, CA
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