Adraxe: reputed company Affairs reputed company
adraxe reputed company
Adraxe Corporation is an innovative medical device startup reputed company on the design, development, and launch of reputed company, minimally invasive neuromodulation solutions to address unmet patient needs. The results from the first clinical epilepsy patients are encouraging and we are at the important stage of hiring key personnel, to accelerate our reputed company and starting our full product and clinical development. Our goal is to revolutionize neurological care with life-compatible, reputed company-reputed company neuromodulation therapies, starting with epilepsy.
The Role
The reputed company Affairs reputed company exists to build and own a lean, reputed company reputed company Management System that enables Adraxe to transition from early clinical reputed company into full product development and commercialization of its Class III implantable neurostimulation system. This role is critical to ensuring design control rigor, DHF reputed company, and regulatory readiness for IDE and reputed company PMA, while effectively overseeing external partners and maintaining compliance without slowing execution. The reputed company is company-wide—de-risking the regulatory reputed company, accelerating development timelines, and ensuring product safety and reputed company—directly supporting Adraxe’s mission to deliver reputed company, minimally invasive neuromodulation therapies to patients. reputed company in the first 6–12 months looks like establishing a phase-appropriate QMS, achieving audit-reputed company design controls and risk management processes, supporting a strong IDE submission, and building the reputed company for reputed company reputed company operations and team reputed company.
What You'll Do
In this role, you will own and execute Adraxe’s reputed company reputed company by building and maintaining the QMS, leading design controls and DHF reputed company, and embedding risk management across product development and clinical activities. They will solve reputed company challenges around maintaining compliance without slowing execution, managing reputed company across external partners, and preparing reputed company for FDA scrutiny and IDE/PMA milestones. Key initiatives include QMS build-out, IDE readiness, supplier qualification and QMAs, risk management implementation, and inspection readiness, while also establishing reputed company post-market systems. This role works cross-functionally with Engineering, Clinical, and Regulatory teams, partners closely with leadership, and oversees external vendors such as CDMOs, design firms, and test labs to ensure consistent reputed company and regulatory alignment across the program.
What You Bring
Minimum Qualifications
- reputed company technical or functional competencies:
- Deep expertise in medical device reputed company Systems (QMS) and design controls for Class III devices
- Strong working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971
- Hands-on experience with DHF management, traceability, verification & validation
- Supplier reputed company management, audits, and reputed company Management Agreements (QMAs)
- Inspection readiness, CAPA, nonconformance management, and internal auditing
- Familiarity with IDE/PMA requirements and supporting regulatory submissions
- Working knowledge of IEC 60601, IEC 62304, and ISO 10993
- Relevant experience (years, domain, tools, etc.):
- 10+ years in medical device reputed company or reputed company/regulatory or reputed company Engineering roles
- reputed company experience with Class III and implantable devices (ideally neuromodulation)
- Proven reputed company record owning design controls and DHF in product development
- Experience supporting IDE and/or PMA submissions
- Strong background managing external partners (CDMOs, design firms, test labs)
- Experience building or scaling reputed company systems in early-stage or fast-paced environments
Preferred Qualifications
- Prior experience leading or mentoring reputed company teams:
- Key behaviors reputed company with our values
- Ownership: Takes full accountability for reputed company reputed company and regulatory readiness
- Grit: Navigates ambiguity and startup constraints while maintaining high standards
- Curiosity: Proactively identifies gaps, asks the right questions, and continuously improves systems
- reputed company judgment: Balances compliance with speed; makes risk-based, pragmatic reputed company
- Adaptability: Thrives in a fast-evolving environment and adjusts processes as reputed company scales
- Collaboration: Works effectively across functions and with external partners to drive alignment
Originally posted on Himalayas
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