Regulatory Project Manager Medical Device

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...

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...

Job Role SummaryAs a Senior Production Process Engineer, you will play a crucial role in leading and supporting the development, optimization, and validation of manufacturing processes for our medical devices. You will work closely with cross-functional teams to ensure compliance with medical device regulations and standards.Key Responsibilities:Process...

RA Strategist in Med TechBondi Chefrekrytering AB is seeking a skilled RA Strategist to join their team.The role involves:Developing and implementing regulatory strategies to ensure compliance with laws and regulations.Providing guidance on regulatory affairs matters throughout the life cycle of medical devices.Acting as a Regulatory Affairs Expert with new...

Nordberg Medical Production Process Engineer:We are seeking a highly experienced Production Process Engineer to lead the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices. As a key member of our production team, you will be responsible for designing, developing, and optimizing manufacturing...

Job SummaryThe Project Manager – MDR Compliance is responsible for leading and coordinating efforts to ensure adherence to Medical Device Regulation (MDR) and related regulatory frameworks. This includes developing project plans, setting goals, managing resources, mitigating risks, and ensuring timely delivery within scope and budget.Oversee the planning,...

Key ResponsibilitiesDesign and oversee clinical studies to meet regulatory and marketing requirements.Collaborate with regulatory affairs teams to secure product approvals.Develop and execute medical affairs strategies to support marketing efforts.Assess and interpret scientific literature relevant to TN Sweden's products.Requirements:MD, PhD, PharmD, or...

As a Quality Assurance Engineer at Capgemini, you will play a crucial role in ensuring the quality of medical devices developed by our clients. Your primary responsibility will be to lead the development of test strategies and execute test engineering work packages in medical device development projects.Key ResponsibilitiesDevelop and implement test...

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...

About the RoleAs a key member of our global team, you will be responsible for ensuring our Quality Management System (QMS) remains updated and compliant with relevant legislation. This includes ensuring correct implementation of the QMS at our headquarters and subsidiaries in Europe and USA.You will also support us in fulfilling regulatory requirements when...

Medical Device Development Tester Wanted!Capgemini Engineering is seeking a skilled and experienced Medical Device Development Tester to join our Compliance, Quality and Regulatory team (CQR). The successful candidate will be responsible for conducting comprehensive testing of medical devices to ensure their safety and efficacy.Key Responsibilities:Conduct...

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...

About the Role:Nordberg Medical is seeking a highly skilled Manufacturing Process Development Manager to lead the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices. This role involves supporting scaling up projects, improving efficiency and product quality, and collaborating with...

About This OpportunityQBtech AB is currently seeking a skilled System Quality Regulatory Manager to join our global team. As the successful candidate, you will play a critical role in maintaining our Quality Management System (QMS) and ensuring its compliance with relevant legislation.Main ObjectivesMaintain the QMS in accordance with relevant legislation...

Job DescriptionQBtech AB is seeking a qualified System Quality Regulatory Manager to oversee the maintenance and implementation of our Quality Management System (QMS). The ideal candidate will possess a strong background in quality management systems, specifically in the medical device industry, and expertise in regulations such as ISO 13485, 21 CFR 820, and...

Capgemini Engineering is looking for a Test Engineering Project Manager to join our Compliance, Quality and Regulatory team (CQR). This role will be responsible for ensuring the quality and integrity of test engineering work packages in medical device development projects. The ideal candidate will have a strong background in test engineering and excellent...

Overview:Getinge provides hospitals and life science institutions with innovative products and solutions aimed at improving clinical results and optimizing workflows. As a Medical Device Design Engineer, you will be part of a cross-functional team responsible for developing user-centered designs for medical devices.We are looking for a skilled engineer to...

Senior RA Specialist Med Tech - Life ScienceBondi Chefrekrytering AB is an innovative and international Swedish medtech company with high potential.Purpose of position:Responsible for regulatory strategy, guidance to the organization on regulatory affairs matters throughout the life cycle of a medical device from product development, placing product on the...

Job DescriptionWe are seeking a Medical Device Installation Engineer to join our team. As a key member of the implementation project and service team, you will be responsible for ensuring successful installations and positive customer experiences.The majority of this position is targeted geographically within either Storstockholm/Mälardalen, Lund or Region...

Are you passionate about delivering exceptional customer experiences? As a Medical Device Field Technician, you'll have the opportunity to make a meaningful impact on patients' lives by providing top-notch technical support for our patient monitoring solutions.As a key member of our implementation project and service team, you'll be responsible for...