Job Description :
Role: FDA Regulatory Consultant Location SFO, CA Duration Long term (2+ Years) Job Description: Providing technical consultation and advise on regulatory strategy, Implementing regulatory requirements in accordance of ISO USFDA/MDD/MDR/MDSAP Contributes with Quality management system development, compliance and improvement programs in line with various directive & regulations for medical device: USFDA QSR, MDD, MDSAP, Usability Ensure compliance to 21 CFR 820, 21 CFR 11, ISO 13485, MDD, MDSAP, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Working experience on FDA registration, Premarket notification, PMA, submission filing. Support pre-and post-market activities including, but not limited to, complaint/MDR handling, design history file remediation, and other remediation activities, Investigational Device Exemptions, pre-market notification applications [510(k)], premarket approvals [PMA], technical files, procedures packs, and design dossiers. Provides Regulatory leadership to development teams, e.g., cross functional alignment with issues of possible Regulatory ramifications and Provide regulatory support for on-going globally product registrations Positive communications and collaboration with all levels of employees, customers, contractors, and vendors Regulatory & Customer & Supplier audit's knowledge, Implementation & Investigation & Trend Analysis of Change Control, Deviation Control, CAPA, Risk Management, Technology transfer etc Product Certification Expert in Medical Device Regulatory, Safety Compliance Certification Execute procedures for implementing CAPAs, Complaints/Feedback, Risk Management and for monitoring their effectiveness. Responsible for submission preparation, filing and development of training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates Prepares submissions for device design changes and /or manufacturing changes Contributes to design assurance activities: safety risk management, usability, design verification and design validation. Conduct quality audits, audit preparation of clients, process validation and other related quality, manufacturing tasks, supplier audits Drafting of worldwide regulatory strategies and worldwide regulatory submissions with minimal supervision Works with manager and project lead to ensure all medical devices projects are in compliance with the R&Q Quality Management System Prepares recall activities as directed by an experienced consultant Work with Customer and US FDA or other regulatory bodies for filing activities What You Need : 8-10 years of related work experience Minimum 3 years in medical device. Bachelor of Science Degree in technical, engineering, and/or a life science discipline. ISO 9001:2015, ISO 13485:2016 certified auditor Regulatory training and certificates. Ability to execute assignments independently as assigned. Must possess strong organizational skills. Must possess strong written and verbal communication skills. Must possess demonstrated ability to handle multiple priorities simultaneously. Proficient in Microsoft Office Products. Working and up-to-date Knowledge of 21 CFR 820, EU MDD/MDR/MDSAP, ISO 13485:2016, and ISO 14971, ISO/IEC 62304, Usability (HFE) IEC 62366 for Medical Devices. Experience of PMA submissions, 510(K) submissions Note: Momento USA is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Thanks, Adam Walsh. Momento USA | Exceeding Customer Expectations 440 Benigno Blvd, Unit#A 2nd Floor. Bellmawr, NJ 08031 Interstate Business Park Direct Number; Tel Ext 1003; Fax Email: Web: Note: Momento USA is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.