Regulatory Product Specialist

5 hours ago


Malmo, Skåne, Sweden Magle Group Full time

Magle Group is a dynamic and innovative company that provides CDMO services and develops and manufactures products with DSM technology. We are seeking a talented Regulatory Affairs Specialist to join our team and support our medical devices business.

This role will involve preparing and submitting regulatory documentation required for approval and registration in various international markets, as well as maintaining regulatory files and updating regulatory authorizations. The ideal candidate will have a strong understanding of international regulatory guidelines and standards, as well as excellent communication skills.

  • Job Description:
  • Preparation and submission of regulatory documentation for new and existing products.
  • Maintenance of regulatory files and update of regulatory authorizations.
  • Response to questions from regulatory authorities.
  • Assessment of device-related incidents and complaints for medical device reporting requirements.

Requirements:

  • Bachelor's degree in a scientific or related field; advanced degree preferred.
  • Minimum of 5 years of experience in regulatory affairs, specifically with medical devices.
  • Strong understanding of international regulatory guidelines and standards.
  • Proven track record in preparing successful regulatory submissions.
  • Excellent communication skills.


  • Malmo, Skåne, Sweden Magle Chemoswed AB Full time

    Magle Group is a dynamic and growing company in the Life Science industry, providing CDMO services and developing products with DSM technology. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory standards and guidelines applicable in our active markets.Key Responsibilities:Prepare and submit regulatory...


  • Malmo, Skåne, Sweden Magle Chemoswed AB Full time

    Magle Group is growing and we are looking Regulatory Affairs Specialist who is looking for a new challenge and who wants to be part of a small but dynamic regulatory team. Magle Group is supporting other Life Science Companies by providing CDMO services as well developing and manufacturing our own products with DSM technology. This role will focus on...


  • Malmo, Skåne, Sweden Magle Group Full time

    We are Magle Group, a value-driven organization that has an interesting journey ahead. We are looking for a talented Regulatory Affairs Specialist to support our medical devices business and ensure compliance with all regulatory standards and guidelines applicable in our active markets.This role will be responsible for preparing and submitting regulatory...


  • Malmo, Skåne, Sweden Magle Group Full time

    Magle Group is a dynamic and innovative company that provides CDMO services and develops and manufactures products with DSM technology. We are seeking a highly skilled Regulatory Affairs Specialist to join our small but dynamic regulatory team. This role will focus on supporting our medical devices business and ensuring compliance with all regulatory...


  • Malmo, Skåne, Sweden Magle Group Full time

    At Magle Group, we believe in making an impact by improving lives for patients worldwide. We are seeking a highly skilled Regulatory Affairs Specialist to join our team and support our medical devices business.This role will involve preparing and submitting regulatory documentation required for approval and registration in various international markets, as...


  • Malmo, Skåne, Sweden Oatly AB Full time

    Oatly AB is looking for a Regulatory Affairs Market Manager to join our team. As a key member of our global regulatory affairs function, you will play a critical role in ensuring that our products meet all applicable regulatory requirements across Europe and international markets.Your primary responsibility will be to provide day-to-day support to our...


  • Malmo, Skåne, Sweden Magle Chemoswed AB Full time

    Magle Chemoswed AB is expanding its regulatory team and seeking a skilled Regulatory Affairs Specialist to support our medical devices business. As a key member of the team, you will be responsible for ensuring compliance with regulatory standards and guidelines applicable in our active markets.Responsibilities:Develop and implement regulatory strategies to...


  • Malmo, Skåne, Sweden Magle Chemoswed Full time

    In this role, you will be part of a talented team dedicated to developing and manufacturing innovative therapies. You will have the opportunity to work on complex projects, develop new skills, and contribute to our mission.The QC Manager will lead and inspire our Quality Control team to achieve analytical excellence and compliance. This involves overseeing...


  • Malmo, Skåne, Sweden Oatly AB Full time

    Regulatory Affairs Market Manager Job SummaryWe are seeking a talented Regulatory Affairs Market Manager to join our team. The successful candidate will have a strong background in food regulatory compliance, with experience working in the European market.In this role, you will be responsible for providing day-to-day support to our business, including...


  • Malmo, Skåne, Sweden Oatly Full time

    Our Commitment to SustainabilityOatly is a leader in the plant-based dairy alternative market, with a strong focus on sustainability and social responsibility. As a key player in this rapidly growing industry, we are committed to creating a better future for our customers, employees, and the planet.We are seeking a highly skilled Regulatory Affairs Market...


  • Malmo, Skåne, Sweden The Studio Group Sweden AB Full time

    The Studio Group Sweden AB invites applications for the position of Data Maintenance Specialist, where you will be responsible for maintaining the integrity and accuracy of product data within our PIM system.Responsibilities:Maintain product data from suppliers to customers in our PIM system, ensuring compliance with regulatory requirements.Handle customer...


  • Malmo, Skåne, Sweden Oatly AB Full time

    We are seeking a Regulatory Affairs Market Manager to support our Europe & International Markets. The ideal candidate will have a strong background in food regulatory compliance, with experience working in the European market.The successful candidate will be responsible for day-to-day support to our business, revising product composition, labeling, and other...


  • Malmo, Skåne, Sweden Oatly Full time

    About the RoleWe are seeking a highly experienced Regulatory Affairs Market Manager to join our team in Malmö, Sweden. In this role, you will be responsible for ensuring that our products comply with all applicable regulatory requirements across Europe and International Markets.You will work closely with our Innovation, Creatives, and Commercial teams to...


  • Malmo, Skåne, Sweden Oatly Full time

    Why Oatly?Oatly is a pioneering company in the plant-based dairy alternative market, with a strong commitment to sustainability and social responsibility. We are dedicated to making it easy for people to turn what they eat and drink into personal moments of healthy joy without recklessly taxing the planet's resources in the process.We are seeking a highly...


  • Malmo, Skåne, Sweden Rasulson Consulting AB Full time

    We are currently seeking a talented Product Development Specialist to join our team at Rasulson Consulting AB. In this exciting consulting assignment, you will be responsible for ensuring that standard products remain up to date and meet high-quality standards. You will serve as a vital link between production, procurement, and other departments.In this...


  • Malmo, Skåne, Sweden 1KOMMA5° Bremen Full time

    Role OverviewWe are seeking a seasoned Product Manager to lead the development and execution of our Heartbeat AI platform in the Swedish market. As our ideal candidate, you will be responsible for defining and implementing a product strategy that aligns with our company's vision and meets the demands of the local market.Main ResponsibilitiesDevelop and...


  • Malmo, Skåne, Sweden 1KOMMA5° Bremen Full time

    Company Overview1KOMMA5° Bremen is a pioneering company in the energy sector, dedicated to revolutionizing the way we consume and produce energy. Our innovative approach focuses on delivering cutting-edge solutions that empower individuals and communities to take control of their energy needs.Job DescriptionAs our ideal candidate, you will play a pivotal...


  • Malmo, Skåne, Sweden 1KOMMA5° Sverige Full time

    About the JobThis is a full-time position based in Malmö, Sweden. The ideal candidate will have a deep understanding of the Swedish energy market and a passion for driving innovation in renewable energy solutions.The job description includes:Bachelor's or Master's degree in Business Administration, Engineering, Renewable Energies, Energy Systems, or related...


  • Malmo, Skåne, Sweden Oatly Full time

    ResponsibilitiesIn this role, you will be responsible for:Developing and maintaining a regulatory network in assigned markets, including monitoring changes in food regulations.Supporting the development of new innovations and lifecycle projects, ensuring product compliance with applicable regulatory requirements.Ensuring recipe and labeling compliance in...

  • QA Manager Role

    6 days ago


    Malmo, Skåne, Sweden Sever Pharma Solutions Full time

    About Our CompanyWe develop and manufacture pharmaceuticals and combination products in line with applicable regulations and industry standards.We strive for excellence in high potent drug development, focusing on delivering results through a collaborative approach.Our QA department plays a vital role in ensuring the quality of our products and services....