Medical Device Regulation Compliance Lead

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...

Empowering Clinical Decision-MakersQbtech AB is a leading global company in professional ADHD tests. Our vision is to empower clinical and financial decision-makers to improve outcomes and support patients to better understand their symptoms and treatment. We are looking for a System Quality Regulatory Manager to join our global team. This role requires...

Senior RA Specialist Med TechThis is an excellent opportunity to become part of a global medtech company with high growth potential.Purpose:Develop and execute regulatory strategies for medical devices throughout their life cycle, from product development to commercial supply and maintenance.Act as the primary point of contact for regulatory affairs with...

RequirementsTo be successful in this role, you will need:A deep understanding of medical device regulations and quality management systemsExcellent communication and interpersonal skillsAbility to work effectively in a team environmentStrong analytical and problem-solving skillsKnowledge of software development and testing methodologies

We are seeking a highly skilled Product Quality Manager to oversee our quality assurance processes in Stockholm. The successful candidate will have a proven track record of ensuring compliant and efficient processes within their previous organisations.ResponsibilitiesEvaluate and qualify new suppliers to ensure they meet our quality standards.Develop and...

Transforming HealthcareQbtech is the global market leader in professional ADHD tests, providing CE marked and FDA cleared tests for use in assessing and treating ADHD. Our vision is to empower clinical and financial decision-makers with leading objective tests, products, and services that improve outcomes and support patients.We are looking for a Medical...

Role Summary:We are seeking an experienced clinical professional to join our team as a Medical Device Strategist. As a key member of our product management team, you will be responsible for developing and executing clinical strategies to support the launch and growth of our ventilation platform.Key Responsibilities:Develop and execute clinical validation...

We are seeking a results-driven and detail-oriented Medical Device Implementation Lead to join our team. In this role, you will be responsible for the successful implementation of patient monitoring solutions at customer sites.The ideal candidate will have a strong background in healthcare technology, with relevant working experience with medical devices and...

We are seeking a highly skilled Implantable Device Manufacturing Specialist to join our team and drive the development, optimization, and validation of our manufacturing processes for implantable Class III medical devices. This role will require around 5-8 years of experience in process engineering within the pharmaceutical or medical device industry, with...

Compliance Expert WantedQbtech, the global market leader in professional ADHD tests, seeks a highly skilled Regulatory Affairs and Quality Manager to join our team.About the PositionThe selected candidate will be responsible for maintaining our Quality Management System (QMS) in accordance with relevant legislation(s). They will also provide critical support...

Job DescriptionTFS 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.About the RoleThe Clinical Compliance Lead...

Job OverviewTN Sweden is seeking a highly skilled and motivated Regulatory Compliance Specialist to join our team in Stockholm. As a key member of our technical team, you will be responsible for ensuring continued compliance with EASA regulations for our devices stationed at Nordic training centres.About the Role:You will serve as the primary liaison between...

Nordberg Medical is committed to fostering a collaborative environment that encourages innovation and creativity. As a Manufacturing Optimization Expert, you will play a key role in driving the development, optimization, and validation of our manufacturing processes for implantable Class III medical devices.This role requires around 5-8 years of experience...

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...

Job DescriptionIn this role as Project Management Expert - Medical Devices, you will be responsible for leading the development of complex medical devices from concept to commercialization. Your primary focus will be on driving project progress and mitigating risks while ensuring alignment with business objectives and regulatory requirements.Key...

Key ResponsibilitiesDesign and implement hardware for a medical electrical stimulator device, focusing on:PCB Design & Layout: Ensure BLE functionality, signal integrity, and regulatory compliance.Schematic Capture & Component Selection: Suit components to medical device standards.Manufacturing Oversight: Manage PCB manufacturing, vendor coordination, and...

About the Role:We are looking for a talented Senior Production Process Engineer to join our team at Nordberg Medical. As a key member of our production department, you will be responsible for leading and supporting the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.Responsibilities:Lead the...

About Our CompanyWe are a leading developer of medical devices and technologies, dedicated to making a positive impact on people's lives worldwide.Our mission is to create innovative solutions that address some of the world's most pressing healthcare challenges.

We are looking for a Regulatory Affairs Manager who can lead our efforts in regulatory strategy development, policy monitoring, and cross-functional collaboration. The successful candidate will have a strong background in regulatory affairs and excellent communication skills.The role reports to the Head of Regulatory Affairs, Quality Assurance, and...

Meaningful WorkAt Qbtech AB, you will have the opportunity to work on something meaningful that helps people understand ADHD while transforming healthcare. As a System Quality Regulatory Manager, you will lead the development of best-in-class products and services globally. You will be part of an international environment together with some of the leading...