System Regulatory Affairs Manager

6 days ago


Stockholm, Stockholm, Sweden QBtech AB Full time

Overview

At Qbtech AB, we strive to make a meaningful impact on healthcare by providing innovative solutions for ADHD diagnosis and treatment. As a System Quality Regulatory Manager, you will play a vital role in ensuring the quality and compliance of our medical devices.

Our company has a strong presence in 14 countries, with offices in Stockholm, London, and Houston. We are committed to investing in new technologies and people to drive growth and innovation in the industry.

The key responsibilities of this role include maintaining the Quality Management System (QMS) in compliance with relevant legislations, coordinating with the Product Development Team, and ensuring document and record control.

Responsibilities

  • Coordinate inspections and audits by notified bodies and authorities.
  • Provide support and advice on Qbtech Management Systems, including ISO 13485, 21 CFR 820, and ISO 27001.
  • Collaborate with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.
  • Perform internal and supplier audits.
  • Ensure document and record control.
  • Responsible for CAPA, Change Control, Complaints, and Non-Conformances.
  • Perform training in quality and regulatory matters.


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    TN Sweden seeks a Regulatory Affairs Manager to join our Medical department. This dedicated and committed team is expanding, with the role reporting to the Head of Regulatory Affairs, Quality Assurance, and Pharmacovigilance.The successful candidate will enjoy working in a small, fast-moving company with an agile approach and strong employee culture. A...


  • Stockholm, Stockholm, Sweden Galderma Full time

    Galderma, the leading dermatology company in the world, is seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring the successful launch of new products and maintaining the existing portfolio in the Nordic region.The ideal candidate will have at least 2 years of experience in Regulatory Affairs in...

  • Regulatory Affairs

    6 days ago


    Stockholm, Stockholm, Sweden Galderma Full time

    Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    ConfidentialSweden - StockholmApply nowPharmaRelations is the market leading Life Science Group in the Nordics. Operating across the Nordics with offices in Sweden, Denmark, Finland, and Norway, we provide expert services that span clinical to post-marketing phases. Our Regulatory interim team is expanding, and we are seeking a consultant to a first...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Permobil is a global company with a presence in over 100 countries, and we are committed to making a positive impact on the lives of people with disabilities.We are seeking a Regulatory Affairs Manager to join our team and help us navigate the complex regulatory landscape and ensure that our products meet the highest standards of quality and safety.The...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Karo Healthcare is a dynamic company that empowers people to make intelligent health decisions. Our goal is to make smart choices for everyday healthcare through a wide-ranging portfolio across seven categories.Job Description:We are currently looking for a Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs to join our headquarter office in...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Are you a communicative and detail-oriented person with the drive to navigate the complex landscape of regulatory and marketing compliance?You now have an opportunity to join a dedicated and committed Regulatory, QA & PV team under expansion, which is a key function within the Medical department at Nordic Infucare. To succeed in the role of Regulatory...


  • Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) - Stockholm Full time

    RaySearch Laboratories AB (publ) - Stockholm is dedicated to developing innovative software solutions to improve cancer care. Our team of experts works tirelessly to ensure that our products meet the highest standards of quality and safety. As a Regulatory Affairs Professional, you will play a key role in ensuring that our products comply with relevant...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    About This Role:We're seeking a detail-oriented and organized Regulatory Affairs Coordinator to join our team in Stockholm. As a key member of the Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements, managing documentation, and coordinating with cross-functional teams.Key Responsibilities:Coordinating with...


  • Stockholm, Stockholm, Sweden Einride Full time

    At Einride, we're not just moving freight; we're reshaping the future of transportation. By harnessing the power of cutting-edge autonomous and electric technologies, we provide freight capacity as a service, accelerating the world along the path toward our shared sustainability goals.Founded in Sweden in 2016, Einride became the first company in the world...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are seeking a highly skilled Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs to join our team in Stockholm, Sweden. As a member of our Regulatory Affairs team, you will be responsible for managing a team to drive maintenance and development of Karo medicinal products.Key Responsibilities:The successful candidate will be responsible...


  • Stockholm, Stockholm, Sweden Adxto AB Full time

    Ready to make an impact in regulatory affairs?We are looking for a Regulatory Affairs Consultant for a consulting assignment with a client in the medical device and pharmaceutical industry. The consultant will play a key role in regulatory project clean-up and master data management, ensuring compliance with evolving regulations and supporting regulatory...


  • Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

    Sobi is a global leader in rare disease treatments, and we're looking for a highly skilled Regulatory Affairs Professional to join our team.Job DescriptionThe Regulatory Affairs Professional will be responsible for ensuring compliance with regulatory requirements and developing and implementing regulatory strategies. This includes working closely with...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are seeking a Regulatory Affairs Manager to join our Medical department at TN Sweden. This role offers an exciting opportunity to work in a dynamic and fast-paced environment, collaborating with cross-functional teams to ensure regulatory compliance.The successful candidate will have a strong background in regulatory affairs, excellent communication...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Pharmaceutical Regulatory Affairs DirectorWe are seeking an experienced Senior Director of Compliance to lead our regulatory affairs strategy in the Nordic region. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and driving business growth through strategic partnerships.The ideal candidate will have a...


  • Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

    ResponsibilitiesAs a Regulatory Affairs and Quality Management Lead, you will be responsible for developing and implementing strategies to ensure compliance with GMP & GDP regulations and Sobi's Quality System. This includes:Overseeing product release, supplier qualifications, and quality technical agreements.Managing quality issues, audits, and change...


  • Stockholm, Stockholm, Sweden Scania Nederland B.V. Full time

    Scania Nederland B.V. is seeking a Regulatory Affairs Professional to join our Vehicle & Compliance team. As a key member of this team, you will be responsible for ensuring that our vehicles meet all regulatory requirements and are compliant with relevant standards.Key Accountabilities:Stay up-to-date with changes to regulatory requirements and ensure that...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Join an ambitious team as Senior Regulatory Affairs Director in Stockholm, shaping regulatory strategies and building a new pharma portfolio for a leader in consumer health. Ready to drive impactful change? Apply nowOur client is one of the leading Sales, Marketing and Distribution companies in Sweden. Their vision is to make brands more successful.This...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    ConfidentialNordics - StockholmJoin an ambitious team as Senior Regulatory Affairs Director in Stockholm, shaping regulatory strategies and building a new pharma portfolio for a leader in consumer health. Ready to drive impactful change? Apply nowOur client, an innovative leader in the consumer health space, is expanding into the pharmaceutical industry....


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Social network you want to login/join with:Our client is a dynamic medical device business at the forefront of biotechnological manufacturing methods and the promotion of cutting-edge biomaterials. Fueled with a commitment to innovate, they utilise their expertise to spearhead new biotechnologies. With robust R&D resources, the company is gearing up for...