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This Regulatory Affairs Specialist position provides regulatory support and leadership to Edwards Lifesciences' Corporate Regulatory Affairs team and cross-functional teams.
The Regulatory Affairs Specialist supports global regulatory submissions, registrations, and product lifecycle activities for OrganOx products, with a focus on regulatory information management and coordination across the Regulatory Affairs function.
This role plays a critical part in ensuring products comply with all regulatory requirements. As a Regulatory Affairs Specialist, you will be responsible for navigating complex regulatory landscapes, supporting customer submissions, and ensuring products meet the highest standards of safety and…
This role ensures that all product licenses in Kosovo are always fully up-to-date and compliant, managing regulatory documentation and submissions. It involves interacting and negotiating with local health authorities and internal stakeholders to achieve successful regulatory outcomes and actively…
This position is responsible for assisting the Regulatory Affairs department, including getting market clearance for Getinge products, contacting factories and NMPA, and other RA operation-related work.
Supporting international regulatory compliance and market access for food supplements is the core of this specialist role. The position evaluates formulations, labelling, claims, and regulatory requirements across global markets, supports product registrations and notifications, and prepares…
This role supports a global medical technology organization by managing documentation, publishing, tracking, and maintaining regulatory compliance for medical technologies across multiple regions.
Stepping into the pivotal role of Regulatory Affairs Specialist at Johnson & Johnson, you will oversee compliance and regulatory strategies for complex medical devices to elevate healthcare solutions.
This role is a vital part of enabling Arxada 's continued growth and market access across the EMEA region, working within the Microbial Control Solutions business area.
This role supports regulatory strategy, submissions, approvals, and compliance activities for medical devices marketed globally. The specialist partners with cross-functional teams and international regulatory stakeholders to facilitate product registrations, support product changes, and maintain…
This role focuses on providing company-wide regulatory support to project teams, spanning both medical and non-medical disciplines, and supporting the QA Director and Regulatory Affairs Manager with operational activities of the Quality Management System and related management systems.
This role involves providing high-quality regulatory suitability and compliance evaluations for Döhler articles across various countries and regions globally.
This specialist role is responsible for all aspects of regulatory submissions in the Philippines, combining scientific and regulatory knowledge to ensure new and established products meet local legislation and company procedures.
Regulatory Affairs Specialists are naturally curious about digital transformation initiatives and innovative ways of working, using critical thinking to identify opportunities for process optimization, continuous improvement, and increased business value.
This role focuses on ensuring the timely registration and maintenance of dental product licenses, while also ensuring compliance with regulatory and corporate requirements.
This role involves managing regulatory affairs for food supplements, ensuring product compliance with regulations in various markets, and supporting product authorization.
Supporting product development teams with regulatory inputs, strategies, and reports is the core purpose of this role. The specialist will also prepare Quality Assurance/Regulatory reports, perform research on regulatory requirements, and maintain material controls to meet various…
The Regulatory Affairs Specialist ensures that all corporate licenses and product clearances comply with FDA standards. This role involves preparing and submitting applications, managing regulatory communications, and maintaining an organized archiving system for all compliance…
Supporting the export drug registration process is the core of this Regulatory Affairs role, working under the Head of Regulatory Affairs. The position involves CTD/ACTD dossier compilation, CDSCO documentation, and registration tracking for active and target export markets.
This specialist role collaborates with the Regulatory Team to interpret global regulations, assists internal and external stakeholders with regulatory compliance, and supports new product development and evaluation.
This position is a key regulatory affairs role within a global life sciences company, responsible for managing regulatory activities across a diverse portfolio including pharma, APIs, and nutraceutical products.
This specialist role supports the EMEA division on all regulatory, quality, compliance, legal, and product stewardship topics for a large portfolio of raw materials supplied to the pharmaceutical industry.
This role involves assisting the Compliance and Regulatory Affairs department in managing, maintaining, and continually improving regulatory systems to meet requirements.
Supporting the planning, execution, and management of regulatory activities for global medical devices, including both software and hardware, is the main focus of this role.
This specialist role in Regulatory Affairs manages the licensing process for Roche's diagnostic products, ensuring patient access to essential tests.
This Regulatory Affairs Specialist role ensures that all products comply with applicable global regulatory requirements throughout their lifecycle, from development and registration to post-market surveillance.
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Regulatory compliance is the core of this specialist role, which supports products and processes in meeting domestic and international regulatory requirements throughout their lifecycle.
Developing and maintaining product labeling that complies with FDA, FSIS, FNS, and international regulations is the core responsibility of this role. The specialist provides regulatory expertise to internal partners and delivers business-minded solutions that support compliance and innovation.
Regulatory compliance activities for medical devices and other regulated products distributed in the United States, Canada, European Union, and other applicable markets are supported by the Regulatory Affairs Specialist.
The Regulatory Affairs Specialist supports regulatory compliance for cosmetic raw materials and finished formulations across global markets. This role is responsible for evaluating ingredient safety, monitoring evolving international regulations, assessing regulatory risks, and providing guidance…
This Regulatory Affairs Specialist role involves coordinating the preparation and submission of regulatory documents for the company's products, ensuring compliance with relevant standards.
This role is for a Regulatory Affairs Specialist to join Dentaid's headquarters in Cerdanyola del Vallès (Barcelona). You will ensure the regulatory compliance of the company's product portfolio, working across teams like R&D and Corporate Marketing to ensure products meet regulatory requirements…
This role is for a Regulatory Affairs Specialist to manage the company's launch licensing, export control, and broader regulatory compliance program. It is a generalist compliance position for someone comfortable working across FAA/AST launch and reentry licensing, ITAR/EAR export control, and the…
This role involves creating, evaluating, and completing regulatory tasks for worldwide product registration submissions, facility registrations, special projects, and strategy to drive market growth globally.
The Regulatory Affairs Specialist supports regulatory compliance and product registration for Koppert Canada, reporting to the Head of Production.
This role involves driving global regulatory strategies and ensuring compliance throughout the product lifecycle of innovative cardiovascular medical devices.
This role involves ensuring that the company's ingredients and products meet regulatory requirements across various markets and applications.
This role is for a Regulatory Affairs Specialist to join the Regulatory Affairs department at the company's Verona office. The specialist will manage regulatory documentation, variations, renewals, and new registrations for medicines, ensuring compliance with national and European…
Supporting regulatory and product stewardship activities for a diverse portfolio of filtration, purification, bioprocessing, and life sciences products is the core of this role.
This role involves developing and executing regulatory strategies for innovative medical devices, software, and AI-enabled technologies.
The Regulatory Affairs Specialist ensures that all new and existing products comply with regulations, providing crucial input to various teams involved in product development, quality assurance, and marketing.
This role supports the department in ensuring that all products purchased and sold fully comply with applicable legislation and European regulations. You will play a crucial role in collecting and managing product information, supplier documentation, and monitoring compliance requirements.
This specialist role drives global regulatory compliance and product submissions for cutting-edge medical devices across domestic and international markets.
This role is a Regulatory Affairs Specialist within the Global Regulatory Affairs team, focusing on medical devices and software solutions.
This specialist role provides leadership in regulatory affairs, focusing on medical device regulations, documentation, and expert consultancy for IZiel Healthcare clients.
Regulatory Affairs Specialists ensure food supplements comply with EU and local regulations, meeting safety, quality, and legal standards.
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This specialist position involves ensuring compliance with FDA regulations, GMP, and industry standards within a pharmaceutical manufacturing environment.
This role involves executing the regulatory strategy for AI/ML-based Software as a Medical Device (SaMD) products, including AidaBreast, with a focus on novel oncology diagnostic technologies.
This role ensures that Roswell Park's Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, along with other regulatory submissions, comply with FDA regulations.
This role supports the registration and lifecycle management of products across a diverse animal-health portfolio as a key member of Elanco's Canadian Regulatory Affairs team.