Regulatory Affairs Officer

Job Title: Regulatory Affairs SpecialistXVIVO is a global medical technology company dedicated to extending the life of organs. We are in a rapid growth phase, expanding geographically and developing new products and supporting processes.Key Responsibilities:Manage vigilance/MDR reporting for markets where XVIVO has a presence.Lead regulatory affairs for...

Job OverviewCochlear seeks a highly skilled Senior Regulatory Affairs Specialist to provide expert regulatory support throughout the lifecycle of our products.This role involves collaborating with R&D, sustaining engineering, and manufacturing groups to ensure compliance with regulatory requirements.

Role Summary:As the Director of Regulatory Affairs, you will play a pivotal role in leading our Regulatory team in Gothenburg and ensuring compliance and timely approvals for acoustics products worldwide. This is an excellent opportunity to work with a global leader in implantable hearing solutions and make a significant impact on a global scale.The ideal...

About AB Volvo\We believe that our employees are our greatest asset, and we're committed to creating an inclusive and supportive environment where everyone can thrive.\As a world-leading supplier of engines and complete drive systems for marine and industrial applications, we're always looking for talented individuals to join our team.\The Job Overview\In...

Role OverviewThe Global Regulatory Affairs Manager for Non-Road and Marine Emissions plays a critical role in driving business success within the Volvo Penta organization. This position requires a unique blend of technical expertise, business acumen, and interpersonal skills, making it an ideal opportunity for those passionate about regulatory affairs and...

Job Description:We are seeking a seasoned professional to lead our CBAS Regulatory team in Gothenburg, ensuring compliance and timely approvals for acoustics products in regulated markets worldwide.Key Responsibilities:Strategic Leadership:Develop and execute global regulatory strategies.Provide critical regulatory insights for Cochlear's Product Innovation...

Job OverviewWe are seeking a highly skilled iGaming Licensing & Compliance Specialist to join our team at TN Sweden.In this role, you will be responsible for ensuring our company's adherence to licensing requirements, managing regulatory certifications, and overseeing all legal contracts related to the online gaming industry.As an iGaming Licensing &...

We are seeking a highly motivated and experienced Mid-Senior Quality Assurance/Regulatory Affairs (QA/RA) Specialist to join our dynamic and rapidly growing MedTech company.This role offers an exciting opportunity to contribute to the development of cutting-edge products while ensuring compliance with the highest industry standards in medical devices.Main...

About the Role:As the Global Regulatory Leader, you will be responsible for leading our Regulatory team in Gothenburg and ensuring compliance and timely approvals for acoustics products worldwide. This is an exciting opportunity to work with a global leader in implantable hearing solutions and make a significant impact on a global scale.The ideal candidate...

Job Title: Global Regulatory CoordinatorXVIVO is seeking a Global Regulatory Coordinator to join our regulatory team.About the Role:The ideal candidate will have a strong understanding of global medical device regulations and be able to apply this knowledge to ensure compliance with regulatory requirements.You will be responsible for managing vigilance/MDR...

Key Challenges:The Director of Regulatory Affairs will lead our CBAS Regulatory team in Gothenburg, ensuring compliance and timely approvals for acoustics products in regulated markets worldwide.Key Responsibilities:Strategic Leadership:Develop and execute global regulatory strategies.Provide critical regulatory insights for Cochlear's Product Innovation...

About Us:Cochlear Limited is a leader in implant, sound processor, and acoustics products.Our Requirements:Minimum Qualifications:Bachelor's degree in a related field with extensive experience in Regulatory Affairs.Knowledge of at least two medical device jurisdictions (e.g., FDA, TGA, EU MDR).Proven experience in healthcare, regulatory affairs, and medical...

Responsibilities:Develop and implement regulatory strategies to support business objectives.Prepare and submit regulatory documents for product approvals.Collaborate with cross-functional teams to ensure regulatory compliance.Evaluate and implement improvements to regulatory processes.Requirements:Relevant education and experience in regulatory...

Key Responsibilities of a Mid-Senior Quality Assurance and Regulatory Affairs SpecialistThe ideal candidate will play a pivotal role in overseeing quality assurance processes, ensuring seamless compliance with regulatory requirements for medical devices.This professional will work closely with cross-functional teams to drive the successful commercialization...

We are seeking a highly skilled Regulatory Compliance and Quality Assurance Expert to join our team at Randstad.This role will involve overseeing the quality assurance process and ensuring compliance with industry regulations.Main Responsibilities:Develop and implement quality systems and regulatory strategies.Collaborate closely with cross-functional teams...

About the Job:Nexer Recruit - Göteborg is seeking a Safety and Compliance Officer (Marine) to ensure that all marine operations are conducted in accordance with relevant regulations and standards.The ideal candidate will have a strong background in QHSE, with experience in developing and implementing QHSE systems, managing risk assessments, and conducting...

Join us at TN Sweden as we redefine the future of sustainable transport solutions.About the PositionAs Lead Legal & Compliance Counsel – Compliance & ESG, you will play a vital role in driving our extra-financial performance initiatives.Reporting to the Assistant General Counsel and Head of Legal & Compliance Strategic Development, you will lead...

EU and UN Regulatory Compliance SpecialistVolvo Group is seeking an experienced regulation specialist to join our team. As an EU and UN Regulatory Compliance Specialist, you'll play a critical role in shaping the future of sustainable transport and infrastructure solutions.We're looking for someone who can influence and monitor regulation development around...

Job Summary:Cochlear is seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our team.The successful candidate will be responsible for providing regulatory support and guidance to ensure compliance with regulatory requirements.Key responsibilities include developing and implementing regulatory strategies, preparing and...

Role SummaryAB Volvo seeks a highly skilled Certification, Regulations & Standards Engineer - Electromobility Systems to join our team.The successful candidate will have a strong background in electrical engineering, mechatronics, or a related field, combined with experience in regulations and standards analysis within the automotive...