Axiom
Legal • SaaS • B2B
Axiom is a company that provides legal services and law-related technology, simplifying the process of managing legal accounts for users. Their focus on accessibility and user-friendly processes highlights their commitment to modernizing the legal experience.
Life Sciences Compliance and Regulatory Affairs Professional
November 21
🇺🇸 United States – Remote
💵 $125k / year
⏰ Full Time
🟡 Mid-level
🟠 Senior
🚔 Compliance
🦅 H1B Visa Sponsor
Axiom
Legal • SaaS • B2B
Axiom is a company that provides legal services and law-related technology, simplifying the process of managing legal accounts for users. Their focus on accessibility and user-friendly processes highlights their commitment to modernizing the legal experience.
📋 Description
• Support regulatory strategy for new products and changes (devices, drugs, combination products, digital health/SaMD). • Help prepare FDA and international submissions (e.g., 510(k), Q-/Pre‑Subs, MDR/IVDR files) and maintain product registrations. • Contribute to EU technical documentation (Technical Files, CERs, Declarations of Conformity). • Help maintain and improve QMS (e.g., ISO 13485, FDA QSR, GMP); draft/update SOPs and templates. • Support internal and external audits, CAPA activities, and remediation. • Assist with Code of Conduct and global policy development (e.g., anti‑bribery, HCP interactions, conflicts of interest, third‑party risk). • Help create and deliver training and communications (e‑learning, live sessions, guides, intranet content). • Support conflicts‑of‑interest processes, hotline and investigations tracking, risk assessments, and culture/engagement surveys. • Partner with Legal, Quality, Medical, Commercial, HR, Finance, IT and others to review projects and contracts for compliance considerations.
🎯 Requirements
• Bachelor’s degree in a relevant field; JD or relevant advanced degree a plus but not required. • 5–10 years’ experience in one or more of: regulatory affairs, quality systems, ethics & compliance, or legal roles in pharma/biotech/medical devices/diagnostics. • Strong writing and communication skills; ability to draft clear policies and training. • Organized, detail‑oriented, and comfortable managing multiple projects and working cross‑functionally. • Strong analytical and problem-solving skills.
🏖️ Benefits
• Health benefits • 401K • Professional development resources • Learning and development programs
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