Medical Device Regulatory Expert

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...

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...

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...

Transforming HealthcareWe are the global market leader in professional ADHD tests, providing CE marked and FDA cleared tests for use in assessing and treating ADHD in individuals aged 6-60.Our vision is to empower clinical and financial decision-makers to improve outcomes by providing a complete system of objective tests, products, and services that support...

Senior Production Process EngineerWe strive to be at the forefront of medical device manufacturing excellence by investing in top talent like you.In this pivotal role, you will lead the development, optimization, and validation of manufacturing processes for implantable Class III medical devices, ensuring seamless collaboration with cross-functional...

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...

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...

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...

About the Position:We are looking for a skilled Medical Device Installation Expert to join our team. As a key member of the implementation project and service team, you will be responsible for servicing and implementing Patient Monitoring solutions at our customer sites.The main goal of your role is to ensure successful implementations and positive customer...

About Nordberg MedicalNordberg Medical is a pioneering biotech company that leverages biomaterial science to restore functionality loss. Our cutting-edge biomaterials enable the development and marketing of innovative medical products addressing structural imbalances associated with aging.Our journey began with a critical milestone, receiving CE...

Med Tech Regulatory Compliance SpecialistThis is an excellent opportunity to work with an innovative Swedish medtech company that has high growth potential.The purpose of this role is:To be responsible for regulatory strategy and provide guidance on regulatory affairs matters throughout the life cycle of medical devices.To act as a Regulatory Affairs Expert...

Empowering Clinical Decision-MakingWe are committed to improving healthcare outcomes by providing innovative solutions for ADHD diagnosis and treatment.As a System Quality Regulatory Manager, you will play a critical role in ensuring our Quality Management System meets the highest standards of regulatory compliance. This includes coordinating inspections and...

Production Process Engineer Job Summary:Nordberg Medical is looking for a seasoned Production Process Engineer to drive the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices. As a key contributor to our production team, you will be responsible for leading process improvements, collaborating...

Job DescriptionTN Sweden is seeking a highly motivated and detail-oriented Regulatory Affairs Manager to join our expanding Regulatory, QA & PV team within the Medical department.This role will provide an exciting opportunity for you to utilize your knowledge of regulatory and marketing compliance in a dynamic environment. As a key member of our team, you...

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...

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...

Process Engineering ManagerWe are looking for an experienced Process Engineering Manager to lead and support the development, optimization, and validation of manufacturing processes for implantable Class III medical devices at Nordberg Medical. This role requires a strong understanding of GMP, ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory...

Job Description SummaryTN Sweden is a leading provider of home infusion therapy for patients suffering from chronic diseases.As a Regulatory Affairs Manager, you will play a critical role in ensuring compliance with regulatory requirements while supporting the growth and success of our company. This role will provide an exciting opportunity for you to...

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...