Job Description: The Regulatory Affairs representative serves as the designated responsible person for global product registration and regulatory compliance activities. This role leads registration, licensing, submission, and documentation activities while acting as the primary regulatory liaison to internal teams, regional representatives, and regulatory authorities to ensure continued market access throughout the product lifecycle.
Key Responsibilities
Product Registration & Approvals: Serve as the designated regulatory representative for product registrations, listings, licenses, notifications, and approvals, ensuring accurate and timely submission to regulatory authorities.
Regulatory Submissions: Prepare, coordinate, and compile European Union Technical Documentation, Canadian and other International Regulatory packages and supporting documentation to meet regional and global requirements.
Stakeholder Liaison: Act as the primary regulatory point of contact for internal and external stakeholders, providing guidance on regional registration requirements and communicating the regulatory impact of product changes. Ensure timely communication with stakeholders to meet regulatory requirements
Cross-Functional Coordination: Coordinate regulatory activities and communications to support submission timelines, project milestones, and alignment with stakeholders.
Documentation & Records Control: Create, review, update, and maintain regulatory documentation and records within approved document management systems in accordance with document control requirements, ensuring records remain accurate, current, and readily accessible for audits, inspections, and submissions.
Compliance & Market Access: Support continued commercialization by ensuring regulatory approvals and registrations are maintained in compliance with applicable regulations and quality system requirements.
Required Regulatory Knowledge
In Vitro Diagnostic Regulation (IVDR): Broad working knowledge of EU IVDR (Regulation (EU) 2017/746) requirements, including classification, conformity assessment, technical documentation, and registration obligations for in vitro diagnostic devices.
Canadian Regulations: Broad knowledge of Health Canada regulatory requirements, including the Medical Devices Regulations (SOR/98-282), medical device licensing (MDL), establishment licensing (MDEL), and applicable registration and listing requirements.
Global Regulatory Frameworks: Familiarity with applicable international regulatory requirements to support multi-region registration, licensing, and ongoing compliance activities.
Documentation Maintenance
Maintain regulatory records and documentation including submission files, registrations, licenses, approvals, and supporting records ensuring version control, timely revision to reflect product or registration changes, and retention in compliance with applicable document control procedures.
Ability to maintain confidentiality of information and materials
Regulatory Analyst I • West Sacramento, CA, US
We're currently seeking motivated individuals to participate in online surveys and paid gaming opportunities for well-known national brands.If you're looking for a flexible way to earn extra cash f... Show more
OverviewCompany Overview:Henkels & McCoy West works closely with clients from diverse markets to build enduring partnerships throughout the Western United States.Our team of seasoned profession... Show more
This position is limited to California Residents and may require travel to Richmond and / or Sacramento, California.UCSD Layoff from Career Appointment :Apply by 8 / 27 / 2025 for consideration wit... Show more
The County of Yuba is currently accepting applications to establish an eligibility list for the position of Business Analyst in the District Attorney's Office.Under general direction, ensures a dep... Show more
ESSENTIAL JOB FUNCTIONS Analyzes global markets for IT Services, servers, storage, backup, IT security, productivity software, remote monitoring services, hyperconvergence and IoT.Studies SMB and m... Show more
Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more
OTCR Business Sector Leader (Operations Technology, Cybersecurity, & Resilience) - Municipal Water.At West Yost, we are a water-focused company that is committed to significant growth over the comi... Show more
Monitor their organization’s networks for security breaches and investigate a violation when one occurs Install and use software, such as firewalls and data encryption programs, to protect sensitiv... Show more
Training users on how to appropriately utilize their computer systems Writing instruction manuals for systems Consulting with managers to determine what role the systems play in the business Testin... Show more
Note : This is an educational program, not a job.Successful completion of the program does not guarantee employment but will equip you with valuable skills for the healthcare job market.Looking to ... Show more
Note : This is an educational program, not a job.Successful completion of the program does not guarantee employment but will equip you with valuable skills for the healthcare job market.Looking to ... Show more
This is an in-person role based in West Sacramento, CA.This position is not remote or hybrid and does not offer relocation assistance.The Raley's Companies is a private, family-owned, and purpose-d... Show more
Assistant Laboratory ManagerAs a night-shift Assistant Laboratory Manager at IDEXX's West Sacramento, CA location, you will be a people leader at one of the largest veterinary diagnostic companies ... Show more
Assists attorneys with the handling of all aspects of litigation including, but not limited to, preparing discovery responses, meeting with staff to obtain necessary information and/or documents; p... Show more
Join ATC West Healthcare , a local California company that truly cares because we take care of you, so you can take care of others.Days, (12x3s)Start Date: 12/09/2025 13 weeks$2,562 weekly (travel)... Show more
We are seeking an experienced Tax Director to join our Private Client advisory practice, specializing in tax planning and compliance for high net worth individuals, families, trusts, estates, gift ... Show more
Wind Harvest is bringing its H-type, vertical axis wind turbines to turbulent mid-level wind resources where traditional turbines can't secure permits or won't operate well.Our answer to this probl... Show more
The Regional Technical Specialist will be responsible for leading the overall revenue and growth in specific areas of business by branch or segment improve profitability and revenue growth.The Regi... Show more
Where You'll WorkInspired by faith.CommonSpirit Health is building a healthier future for all through its integrated health services.As one of the nation's largest nonprofit Catholic healthcare org... Show more
Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more
