SharkNinja
ComplianceEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Compliance Engineer at SharkNinja. Skills: Regulatory compliance, Product certification, Risk management, Medical device regulations. Support certification activities. Support risk analysis”
What You'll Achieve.
Ensure market access requirements met; Incorporate risk mitigation solutions; Meet market access requirements; Ensure product designs incorporate risk mitigation
Industry & Context.
Risk mitigation; Contingency planning; Regulatory strategy adjustments; Creative solutions; Technically sound solutions
What They're Looking For.
Must Have
2–4 years compliance experience, 2–4 years design experience
Nice to Have
RAC certification a plus, Familiarity with international medical device regulations, Experience interfacing with FDA, Experience interfacing with Notified Bodies, Experience interfacing with accredited test laboratories
What You'll Do.
Support certification activities
Support risk analysis
Assist preparing regulatory filings
Maintain Design History Files
Support establishment of project needs
Support establishment of deliverables
Execute risk management activities
Support usability engineering processes
Evaluate project risk
Support contingency planning
Participate in weekly reviews
Present project risks
Assure product certification activities execute
Support product development teams
Provide counsel on medical device requirements
Contribute to continuous improvement
Contribute to special projects
How You'll Work.
Team & Collaboration
Partner with global product developers; Work with third-party partners; Intradepartmental collaboration
Communication Scope
Presenting status; Presenting risks; Providing counsel
Process & Methodology
Product lifecycle management
Full Job Description
About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world. AI at SharkNinja At SharkNinja, we’re building an AI-native culture. We’re not waiting for the future; we’re creating it. Our people are expected to experiment boldly, adopt new tools, and continuously raise what’s possible to create meaningful impact for our consumers. If you believe the best way to do your job hasn’t been invented yet, you’ll fit right in. The Product Compliance Engineer will partner with global product developers and certification partners on regulatory compliance and product certification. The candidate will support certification projects from product concept to mass production, ensuring market access requirements are met and that product designs incorporate appropriate risk mitigation solutions. This role includes participation in medical device regulatory pathways alongside our consumer and commercial product portfolio. Here are some of the EXCITING things you'll get to do: · Support the execution of certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745. · Assist in preparing regulatory filings including FDA 510(k) submissions and Technical Files/Design Dossiers, and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design Controls and
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