LOCATION
U.S. - Remote
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 Regulatory Affairs Advertising and Promotions Lead.
- Press: Inari in the News
- Revenue: Inari Q2 2023 Financials
- ClotTriever: The ClotTriever System
- FlowTriever: FlowTriever Retrieval/Aspiration System
We have partnered with Kit Cariquitan, Vice President of Quality Assurance and Regulatory Affairs, to hire our Lead RA, Ad & Promo. This position will evaluate and manage the advertising and promotion compliance in Inari Medical. Our RA Ad & Promo Lead will oversee the process for reviewing marketing and labeling materials, improve review efficiencies, and work cross functionally with marketing on claims.
POSITIONDETAILS
- Conduct regulatory promotional labeling and marketing compliance reviews in the pre and post market space to help ensure that activities and communications are consistent with product labeling, are adequately supported and are following applicable laws, regulations and policies related to advertising and promotion of prescription products.
- Partner with key stakeholders to determine the impact of labeling changes and evolving clinical evidence on the advertising and promotion of products.
- Help ensure compliant growth under applicable laws, regulations, guidelines by strategically supporting the business and addressing problems/opportunities by generating alternatives to achieve desired outcomes. Clearly articulate any potential risks, along with rationales and anticipated likely outcomes.
- Provide promotional regulatory input on concepts and draft materials to help assure promotional materials satisfy US and international promotional regulations and business objectives.
- Facilitate productive conversations to develop viable alternatives and solutions to help accomplish the identified communication goals.
- Identify issues and facts that may be impacted by and subject to applicable laws, regulations, guidelines and company policies; and helping to develop alternatives to avoid any misperception in the respective communication while achieving the desired communication outcome outcomes.
- Partner with key stakeholders across multi-disciplinary teams to ensure a collaborative, compliant, and efficiently organized and efficient ad/promo review process.
- Undergraduate degree in a healthcare or science-related field.
- Regulatory affairs experience in the medical devices or pharmaceutical industry, including significant experience in pre and post market promotional material development and advertising/promotion compliance and review
- Working knowledge of FDA and international regulatory promotional practice laws, regulations, policies, guidelines and enforcement trends.
- Highly organized with an exceptional attention to detail.
- Demonstrated ability with complex problem solving.
- Excellent written and verbal communications.
- Proficiency in Microsoft Office programs.
- Continuous improvement mindset.
- At least 4 years of experience in pre and post market promotional material development, advertising/promotion compliance and review
- Expert understanding of legal and regulatory environment in medical device or pharmaceutical promotions, industry guidelines, and other compliance-related issues.
- Understanding of clinical study design and statistical analyses in assessment of promotional claims
- Exceptional communication skills, including excellent writing skills, are a must and can adapt to challenging and/or changing stakeholder needs to successfully support the business.
- Understanding of best practices in medical device or pharmaceutical industry advertising and promotion operations
- Ability to travel to Irvine headquarters
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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Senior Director, Quality Engineering
Irvine, CA
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