Senior Regulatory Affairs Specialist

February 11

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Aryma Labs

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Aryma Labs is a global company specializing in marketing efficiency and effectiveness in a privacy-first era. They leverage advanced data science solutions, including Marketing Mix Modeling (MMM), causal inference, and experimentation, to help enterprises optimize their marketing performance and return on investment (ROI). Aryma Labs offers a comprehensive suite of products such as ArymaEdge, MMMGPT, and MMMDiagnose, designed to provide insights into marketing attribution and efficiency across various channels. Their services are tailored to enterprises of all sizes, aiming to reduce costs and improve marketing strategies' outcomes. With a focus on privacy-compliant marketing measurement, Aryma Labs helps clients worldwide navigate marketing measurement gaps, providing robust models and insights for enhanced decision-making.

Natural language processing • Artificial Intelligence • Data Visualization • Digital Analytics • Data Science

2 - 10 employees

🤝 B2B

🏢 Enterprise

☁️ SaaS

📋 Description

• Responsible for maintaining Aerin quality system to meet applicable regulatory requirements • Provide regulatory expertise to R&D, marketing and quality functions on regulatory standards and requirements • Lead the preparation and submission of product registration application/dossier for new medical devices and modifications to existing devices • Ensure device complies to 21 CFR 820 and EU MDR requirements • Collaborate with cross-functional team members in preparation activities for responses to regulatory authority queries • Communicate directly with regulatory authorities such as FDA, Health Canada, the EU Authorized Representative, Competent Authorities and/or Notified Bodies • Monitor, maintain and track product registration licenses and validity status • Create and maintain device technical documentation • Prepare and submit post-market vigilance, adverse event, product field corrective action, recall, advisory notice and related documents to regulatory authorities • Review and approve product label and promotional materials for compliance with applicable regulations

🎯 Requirements

• Bachelor’s degree or diploma preferably in a Scientific, Engineering or similar discipline • At least 3 or more years of experience in regulatory affairs and/or quality management systems in medical device industry is required • Good understanding of ISO 13485, EU MDD/MDR, FDA QSR 21 CFR Part 820, and ISO 14971 is required • Must have hands-on registration experience with FDA 510(k), and EU MDR product submissions • Experience with MDSAP is advantageous • Experience in promotional material review is beneficial • Prior working experience in a manufacturing and/or device design authority environment preferred • Experience with single-use sterile devices, biological safety, devices containing software, cybersecurity requirements is desired • Self-motivator with strong sense of ownership on assigned responsibility • Capable of driving results through others • Proactive with resilient drive towards achieving department and organization’s goals • Resourceful and possess good problem-solving skills • Demonstrated ability to work collaboratively with cross-functional departments and stakeholders in a constructive manner • Ability to view issues from a broad and detailed perspective • Excellent interpersonal and communication skills (both verbal and written) and capable of effective communication with all levels of organization

🏖️ Benefits

• Medical – PPO & HSA with co-contribution • Dental • Vision • Accident Insurance • Critical Illness • Hospital Indemnity • Onsite Tonal & Peloton • HSA/FSA • 401k with company match • Lifestyle Spending Account • Long Term Disability • Life Insurance • Monthly stipend to cover phone and tech costs • Employee discounts • Weekly office lunches • Employee Assistance Program • 5 free counseling sessions per issue per year • 80 hours sick leave • 13 holidays • Flexible vacation (exempt employees) • Career and Learning & Development opportunities with Aerin led leadership trainings • Community initiatives which include Aerin “give back” week • Family days as well as Aerin holiday giving