MDR Regulatory Project Lead

TN Sweden is a mid-size Contract Research Organization (CRO) offering innovative solutions for biotechnology and pharmaceutical companies. Our services include full service capabilities, resourcing and Functional Service (FSP) solutions.The Regulatory Affairs Specialist – MDR Compliance plays a crucial role in ensuring adherence to Medical Device...

About UsWe are TFS HealthScience, a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Our team provides full service capabilities, resourcing, and Functional Service (FSP) solutions to support clients' needs in the field of medical...

At TN Sweden, we are a leading global 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 Clinical Lead MDR is responsible for leading and coordinating...

TN Sweden is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We offer full service capabilities, resourcing and Functional Service (FSP) solutions.The Project Manager – MDR Compliance leads and coordinates efforts to ensure adherence to Medical Device...

TNF Sweden is a global Contract Research Organization (CRO) offering innovative solutions for biotechnology and pharmaceutical companies. Our services include full service capabilities, resourcing and Functional Service (FSP) solutions.The Project Coordinator MDR Compliance supports the team in ensuring adherence to Medical Device Regulation (MDR) and...

Key ResponsibilitiesThe Project Manager – MDR Compliance is responsible for:Leading and coordinating efforts to ensure adherence to Medical Device Regulation (MDR) and related regulatory frameworks.Developing project plans, setting goals, managing resources, mitigating risks, and ensuring timely delivery within scope and budget.This is a full-time position...

About This RoleTFS 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. We are dedicated to supporting our clients'...

Dentatus AB is looking for an experienced Regulatory Compliance Manager to join their team. The ideal candidate will have a strong understanding of ISO 13485, ISO 14971, and MDR 2017/745 requirements. They will lead the creation and revision of MDR technical documentation, ensure products meet regulatory standards, and drive product compliance.Key...

Promote Project is seeking an experienced Electric Vehicle Regulatory Compliance Lead to join our team immediately.The ideal candidate will have a strong background in automotive compliance, particularly in electric vehicle systems and charging infrastructure.Main Responsibilities:Manage and oversee compliance matters as a regulatory expert.Conduct thorough...

About TFS HealthScienceWe are a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey.Our team provides full service capabilities, resourcing, and Functional Service (FSP) solutions to support clients' needs in the field of medical devices...

Required Skills and QualificationsTo be successful in this role, you will need:Minimum three years of experience in project management.Strong knowledge of MDR and regulatory compliance frameworks.Experience in implementing regulatory policies and management systems.Additionally, you should have strong communication and problem-solving skills, as well as...

Key Responsibilities:Develop and manage Quality Management System (QMS) processes to ensure compliance with medical device regulations (MDR, ISO 13485, FDA).Support management of CAPA, non-conformance, change management, and audits.Conduct QA reviews, investigate non-conformance, and manage CAPA.Analyze quality data and identify training needs.Address...

About this roleTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.We provide full service capabilities, resourcing, and Functional Service (FSP) solutions to support clients' needs in the field of medical devices...

Company OverviewTFS HealthScience is a leading global Contract Research Organization (CRO) that partners with companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions, including expertise in Medical Device Regulation (MDR) compliance.

At Promote Project, we help Scandinavian businesses find and work with top tech talent.We focus on long-term, full-time remote collaborations that drive growth.Job Overview:We are seeking an experienced Regulatory Affairs Specialist to join our team immediately. The ideal candidate will have a strong background in automotive compliance, particularly in...

The Dental Product Development Lead at Dentatus AB will play a crucial role in driving product innovation and regulatory compliance. The ideal candidate will have experience in medical device manufacturing or production, adherence to GMP and GDP standards, and a strong understanding of ISO 13485, ISO 14971, and MDR 2017/745 requirements.Key...

Job DescriptionSenior Manager, Regulatory SciencesWe are seeking an experienced Senior Manager, Regulatory Sciences to join our team in Stockholm. The successful candidate will have a strong background in regulatory affairs and excellent leadership skills.About the CompanyTN Sweden is a leading consultancy specializing in regulatory sciences. We work closely...

Quality and Regulatory ExpertiseQBtech AB is searching for a seasoned System Quality Regulatory Manager with extensive experience in quality management systems, particularly in the medical device industry. The ideal candidate will possess a deep understanding of regulations such as ISO 13485, 21 CFR 820, and EU-MDR 2017/745, as well as exceptional...

Job DescriptionCompany OverviewBTR Group is a leading Employer of Record & Accounting provider, offering comprehensive solutions to businesses worldwide.Job SummaryWe are seeking an experienced Technical Project Lead to join our team. As a key member of our Unit, you will be responsible for driving critical package deliverables, resources, assurance...

Dentatus AB is seeking a highly skilled Medical Device Project Manager to coordinate projects related to product support and improvements. The ideal candidate will have experience in medical device manufacturing or production, adherence to GMP and GDP standards, and a strong understanding of ISO 13485, ISO 14971, and MDR 2017/745 requirements.Key...