MDR Regulatory Expert

About this Role at TFS HealthScienceTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.The Project Manager –...

As a key member of the TFS HealthScience team, you will be responsible for leading and coordinating efforts to ensure adherence to Medical Device Regulation (MDR) and related regulatory frameworks.About This RoleThis is a full-time position (1.0 FTE) in a hybrid working setting, requiring on-site presence as well as remote flexibility.You will collaborate...

Role Overview: Project Manager – MDR ComplianceTFS HealthScience is a leading global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service (FSP) solutions.The Project Manager – MDR...

Key ResponsibilitiesDevelop, manage, and review Quality Management System (QMS) processes,Ensure QMS compliance with medical device regulations (MDR, ISO 13485, FDA),Support the management of CAPA, non-conformance, change management, and audits,Review QMS efficiency, focusing on key processes and reporting,Conduct QA reviews, investigate non-conformance, and...

The ideal candidate will have a strong background in project management, with experience in regulatory affairs and compliance.Job RequirementsYou will be responsible for:Developing and implementing project plans and timelines.Coordinating with cross-functional teams to ensure smooth project execution.Managing risks and issues that may arise during project...

Job Description:We are seeking a highly skilled and experienced Regulatory Compliance Expert to join our dynamic and international regulatory compliance advisory team at Nasdaq, Inc. Our team is dedicated to supporting 8 Nasdaq Exchanges and Nasdaq Clearing with compliance advisory services for the reporting obligations in regulations such as MIFID II/R,...

At Alfa Laval Corporate AB, we're pushing the boundaries of what's possible. We're a pioneer in developing sustainable solutions for the future. As a Product Regulatory Expert, you will play a crucial role in ensuring our products meet all relevant regulatory standards.Company OverviewAlfa Laval Corporate AB is a global leader in the development and...

About UsKaro Healthcare is a leading organization in the pharmaceutical industry, committed to making smart choices for everyday healthcare. We own and sell over 80 brands in about 90 countries, catering to various needs and preferences of our customers.Role and ResponsibilitiesThe successful candidate will lead a team of experts responsible for managing...

At Aira, we are driving the clean energy revolution. Our mission is to advance the next generation of home energy solutions, creating intelligent, sustainable homes for a meaningful impact. As a Regulatory Compliance Expert, you will play a crucial role in ensuring our organization complies with all applicable laws, regulations, and industry standards.About...

Transforming Healthcare with Medical DevicesQbtech is a global market leader in professional ADHD tests, providing solutions that empower clinical and financial decision-makers to improve outcomes and support patients.We are committed to transforming healthcare by providing a complete system of leading objective tests, products, and services. Our vision is...

About this opportunityWelcome to the Model Risk and Validation team at TN Sweden. We add value by advising and challenging the business areas and functions to use models within the bank's model risk appetite. As a Regulatory Expert - Model Risk, you'll play a valuable role in advising stakeholders in complying with model-related regulatory...

Job SummaryProPharma Group is seeking a Senior Manager, Regulatory Sciences to lead client projects, ensuring efficient project execution and contributing to larger projects.ResponsibilitiesProject manage assigned projects, including approval of time entry and invoicing, budget monitoring, and client liaison.Provide expert guidance and technical expertise,...

AML Subject Matter Expert (E-commerce)We are seeking a qualified professional to fill the role of AML Subject Matter Expert. This individual will play a crucial role in ensuring compliance with anti-money laundering (AML) regulations and establishing effective AML frameworks.Key Responsibilities:Design, implement, and optimize AML processes tailored to...

The Project Manager – MDR Compliance is responsible for ensuring that all projects are delivered on time, within budget, and to the required quality standards.Key ResponsibilitiesYou will oversee the planning, execution, and completion of projects related to MDR compliance.Develop and implement strategies to align with regulatory requirements.Coordinate...

Job OverviewAt Spotify, we are seeking a highly experienced Regulatory Compliance Specialist to develop and implement global compliance programs tailored to technology regulations.Key Responsibilities:Develop and implement comprehensive compliance strategies for digital platforms, artificial intelligence, video, and social media regulations.Maintain...

Job OverviewTN Sweden is seeking an experienced Director of Regulatory Reporting to lead our team in ensuring compliance with regulatory requirements. This role focuses on data quality, operational controls, and regulatory monitoring.The ideal candidate will have extensive experience in regulatory reporting within the financial services industry, with a...

We are seeking an experienced Regulatory Affairs professional to join our team at Scandinavian Biopharma. As a key player in our company's growth strategy, you will be responsible for ensuring the regulatory compliance of our vaccine products.Job DescriptionCoordinate regulatory activities related to CMC changes, including updates to manufacturing processes...

Job DescriptionAs a Regulatory Compliance Specialist at TN Sweden, you will play a critical role in ensuring the continued compliance of our devices with EASA regulations. Your responsibilities will include serving as the primary liaison between our training centre and technical managers, assisting in maintaining schedules for FSTD evaluations, and...

We are on the hunt for a seasoned professional to fill the role of Regulatory Affairs Specialist at Albion Rye Associates. This position requires an individual who is passionate about regulatory compliance and has a proven track record in ensuring seamless operations within the biotech and pharmaceutical industries.Main responsibilities include: Developing...

Risk Management and Cybersecurity Expert WantedAt Qliro AB, we are looking for an experienced Chief Information Security Officer - Regulatory Compliance Expert to lead our ISRM team. The successful candidate will be responsible for driving education and awareness programs to ensure security and privacy understanding at all levels, from employees to the...