Remote Regulatory affairs Jobs

Responsible for delivery of site activation readiness, preparation of Clinical Trial Application Forms, and interaction with CA/EC for study purposes. Providing updates about submissions, maintaining project plans, and customizing Patient Information Sheets. Act as SME for collection and maintenance of site level critical path to Site Activation data points. May support the clinical team performing Pre-Study Site Visits.

As a Senior Regulatory Affairs Engineer at Neko Health, you will assign product codes and IDs, own product registrations, maintain establishment listings and reporting, manage legal representatives, drive regulatory intelligence, support product development, and empower process owners and teams. Your role involves keeping registrations of multiple devices in multiple markets current.

Ensure our cutting-edge medical devices meet global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market. You will advise on regulatory strategy throughout the product lifecycle, influencing design, risk management, supplier selection, and device labeling. You will also prepare and submit documentation for EU MDR, FDA, and other international markets.

This leader will shape and lead value and access submission and negotiation planning, including optimal country launch sequence and ensure sustainable access in key European markets. This role will be a core member of the Europe Region leadership team, working cross-functionally to influence long-term growth and patient impact, to build a global multi-billion company serving patients suffering from rare neuro-muscular diseases.

The Senior Regulatory Manager plays a key role in leading regulatory strategy and ensuring compliance across our diverse product ecosystem, from supplements and cosmetics to diagnostic test kits and food products. You’ll lead and empower a growing Regulatory team, work collaboratively with Quality, Legal, Distribution, and Brand teams, and provide strategic oversight for regulatory readiness, audits, labeling compliance, and supplier qualification.

The Senior Director of Regulatory Affairs will develop and execute global regulatory strategies in collaboration with key stakeholders, serving as the global regulatory lead for the multifocal motor neuropathy (MMN) program and supporting other programs as needed. You will provide expert guidance to cross-functional teams, driving global regulatory submissions, acting as primary liaison with Health Authorities, and interpreting applicable Health Authority regulations and guidance documents to ensure compliance.

As a Healthcare Regulatory & Compliance Specialist I, you will develop and update compliance templates, policies, checklists, competency assessments, and other related resources. You will also research, interpret, and link federal and state regulations, accreditation standards, and evidence-based practices to MedTrainer solutions. You will collaborate with cross-functional teams to ensure the timely delivery of compliance projects and initiatives.

We’re seeking a Manager of Regulatory Affairs to support ARMRA’s compliance efforts across product lines, marketing, and operations. This role requires strong knowledge of dietary supplement regulations and the ability to collaborate effectively with cross-functional teams. Reporting to the Senior Director of Regulatory Affairs, you’ll work closely with Marketing, Product Development, Quality Assurance, and Science teams to ensure compliance.

Supports North America Regulatory activities and ensures timely preparation and completion of technical file submissions for in vitro diagnostic devices to meet project and business needs. This role requires participating on cross functional project teams to provide strategic and tactical guidance to meet regulatory requirements, develop North America regulatory strategies plan for submission for IVD products, and assess changes to product and manufacturing processes.

Are you ready to take your career to the next level? Join our dynamic team at SGS and become a Senior Product Assessor - Active Devices where you will manage a small team of globally based Product Assessors and dive deep into the exciting world of Active Medical Devices. As a member of our Medical Device team you will conduct thorough technical documentation reviews and ensure compliance with EU regulations and standards.