Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)

About the role

The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe, effective and high-quality medical products for at home, mobile health and wellness customers.

Requirements

• 7+ years of working directly with engineering teams experience
• 5+ years of technical product or program management experience
• 5+ years of technical program management working directly with software engineering teams experience
• Experience managing programs across cross functional teams, building processes and coordinating release schedules
• Experience with regulatory filings and reports or equivalent
• Experience that includes strong analytical skills, attention to detail, and effective communication abilities, or experience working with customers with a passion for delivering exceptional service
• Experience working on multi-team, cross-disciplinary projects
• Experience that includes strong analytical skills, attention to detail, and effective communication abilities
• Experience in identifying incomplete or inaccurate data, identifying the root cause and creating/implementing an escalation plan, or experience communicating results to senior leadership
• Bachelor's Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)
• 5 years of experience working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
• 5 years of experience in a regulated industry with experience working with Class II and/or Class III devices.
• Knowledge and understanding of guiding principles in device development such as benefit/risk profile, sta
• develops global regulatory strategies for new and modified products.
• prepares and submits regulatory submissions to health agencies.
• provides regulatory assessment for manufacturing, design changes and product risk assessment.
• reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations.
• plans, schedules, and arranges all activities to support regulatory timelines.
• supports the product release process.
• acts as an sme for internal and external audits and inspections by internal teams or external regulatory authorities.
• maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• reviews protocols and reports to support regulatory submissions.
• creates, reviews and approves engineering change requests.
• acts as liaison between the company and the various regulatory agencies. interfaces directly with fda and notified bodies.
• provide interpretation of regulatory authorities' feedback, policies and guidelines.
• critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams

Additional Information

Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and devices like Fire tablets, Fire TV and Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. They must enjoy problem solving and possess practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for medical products. Key job responsibilities - Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. - Develops global regulatory strategies for new and modified products. - Prepares and submits regulatory submissions to health agencies. - Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures. - Provides regulatory assessment for manufacturing, design changes and product risk assessment. - Reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations. - Plans, schedules, and arranges all activities to support regulatory timelines. - Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during regulatory audits. - Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements. - Supports the product release process. - Acts as an SME for internal and external audits and inspections by internal teams or external regulatory authorities. - Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, and governing procedures and processes. - Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. - Reviews protocols and reports to support regulatory submissions. - Creates, reviews and approves engineering change requests. - Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies. - Provide interpretation of regulatory authorities' feedback, policies and guidelines. - Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams

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