Regulatory Affairs Specialist

2 weeks ago

Helsingborg, Skåne, Sweden Magle Group Full time

Magle Group isgrowing and we are looking Regulatory Affairs Specialist who is looking for a new challenge and who want to be part of a small butdynamic regulatory team.Magle Group is supporting other Life Science Companies by providing CDMO services as well developing and manufacturing our own products with DSM role will focus on supporting ourmedical devices business and assure wecomply with all regulatory standards and guidelines applicable in our active markets.The Regulatory Affairs Specialist plays acrucial role in the submission, registration, and lifecycle management of our medical device products.

Key Responsibilities:

  • Prepare and submit regulatory documentation required for the approval and registration of new and existing products in various international markets.
  • Be updated of regulatory procedures and changes in the regulatory climate to ensure compliance and advise the company on necessary adjustments.
  • Legalization of registration documentation.
  • Inform and educate the organisation onsubmission requirements and ensure necessary documents are provided.
  • Maintain regulatory files and update regulatory authorizations, such as Investigational Device Exemptions (IDEs), 510(k) submissions, Canadian medical device licenses, and CE dossiers for the EU, as well as NRTL certifications.
  • Maintenance of registrations , renewals, device listings, site registrations, supplements for changes, and annual reports.
  • Respond to questions from regulatory authorities.
  • Change control activities
  • Assess device-related incidents and complaints for medical device reporting requirements.Compile and submit reportable events to relevant regulatory authorities in a timely manner.Handle recalls and field actions, if required.
  • Review and create product labels and review promotional materials to ensure compliance with applicable regulations and technical standards.
  • Assist in preparing clinical trial site ethics review board applications for investigational device trials.Prepare interim or final reports for trial site ethics boards as required.
  • Other duties as assigned to support the regulatory team and ensure compliance with global regulatory requirements.

Qualifications:

  • Bachelor's degree in a scientific or related field; advanced degree preferred.
  • Minimum of 2 years of experience in regulatory affairs, specifically with medical devices.
  • Strong understanding of international regulatory guidelines and standards such as FDA, CE Marking, NBOG,ISO 13485, etc.
  • Proven track record in preparing successful regulatory submissions.
  • Excellent communication skills, both written and verbal, with the ability to interact effectively at all levels of the organization and with regulatory authorities.
  • Highly organized and able to manage multiple projects simultaneously in a fast-paced environment.

Meriting:

  • Experience with Class II and Class III medical devices.
  • Familiarity with regulatory landscape in key international markets (e.g., Europe, Asia, and North America).
  • Proficient with regulatory submission software and document management systems.

If you find the above position interesting, itfits your experience and you want to join a company who has interesting journey ahead, we would love to hear from you.We are a value driven organization and we expectyou to share our passion to make an impact by making life better, therefore we also look to find a person who not only fit the qualifications but also shares our values and fit our organisation personal wise.

In this process we will have an continuous recruitment, please submit your CV and a short cover letter telling us why you find the position interesting.The position is placed at our office in Malmö and will be a full time position.To find out more about us please visit our group webb page.

#J-18808-Ljbffr

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Helsingborg, Skåne, Sweden Alliancesrcare Full time

    Select how often (in days) to receive an alert: Senior Specialist Regulatory Affairs - Nordics Job Title: Senior Specialist Regulatory Affairs Location: Helsingborg About ADVANZ PHARMA ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing the specialty, hospital, and rare disease medicines they depend...

  • Supply Specialist

    2 weeks ago

    Helsingborg, Skåne, Sweden Teva Pharmaceuticals Full time

    The opportunityDo you wish to have a job where you can put all in for better health? Looking for a feeling of being able to contribute every day? Would you be inspired by being part of one of the largest pharmaceutical supply chains in the world? If you are looking for an exciting career opportunity in supply chain, this could be just the place for you. We...

  • Product Manager Animal Nutrition

    2 weeks ago

    Helsingborg, Skåne, Sweden Perstorp Group Full time

    Perstorp Animal Nutrition is looking for a curious and motivatedProduct Manager Animal Nutrition(Full-time)What will you be doing?As Product Manager you will be responsible of leading key projects for the development and growth our feed Hygiene andPreservation product portfolios.The main responsibility of the product manager will be to rally different...

  • Supply Specialist

    2 weeks ago

    Helsingborg, Skåne, Sweden Tevapharm Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds....

  • Quality Assurance specialist

    2 weeks ago

    Helsingborg, Skåne, Sweden Kenvue Inc Full time

    Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - Quality Assurance specialist W) Quality Assurance specialist W Description Kenvue is currently recruiting for: Quality Assurance Specialist This position reports into Quality & Compliance and is based at Helsingborg. ...

  • Manager Quality Management

    2 weeks ago

    Helsingborg, Skåne, Sweden Occlutech Full time

    Occlutech is a leading specialist provider of minimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a global leading specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure. Occlutech has a broad and proven...

  • Mechanical Design Engineer

    2 weeks ago

    Helsingborg, Skåne, Sweden aira Full time

    Clean energy technology plays a crucial role in positively transforming the global landscape. In Europe, household heating stands out as a significant contributor to 15% of CO2 emissions. By transitioning to sustainable solutions, households can pave the way towards achieving net-zero emissions.About AiraAira is dedicated to advancing the next wave of home...

  • Quality Manager to Oatly Landskrona

    2 weeks ago

    Helsingborg, Skåne, Sweden Oatly AB Full time

    THE OATLY WAYOatly is a company built on the idea of change. Our mission is to help people upgrade their everyday lives and the health of the planet by making tasteful oat-based food products accessible to a wider audience in a world-class manner. It's why we come to work every day. With head office in Malmö and production in Sweden, Netherlands and the US,...

  • Regulatory Specialist

    1 month ago

    Helsingborg, Sweden John Bean Technologies Corporation Full time

    Overview ... We are looking for a Regulatory Specialist to join our team in Helsingborg! We are looking for a Regulatory Specialist to join our team on-site in Helsingborg. You will work as an internal specialist, supporting different projects and engineers in the EMEA region with your expertise in regulatory requirements. To make the best out of it you will...

  • Regulatory Specialist

    4 weeks ago

    Helsingborg, Sweden John Bean Technologies Corporation Full time

    Overview ... We are looking for a Regulatory Specialist to join our team in Helsingborg! We are looking for a Regulatory Specialist to join our team on-site in Helsingborg. You will work as an internal specialist, supporting different projects and engineers in the EMEA region with your expertise in regulatory requirements. To make the best out of it you will...

  • Supply Specialist

    4 weeks ago

    Helsingborg, Sweden Teva Pharmaceuticals Full time

    The opportunityDo you wish to have a job where you can put all in for better health? Looking for a feeling of being able to contribute every day? Would you be inspired by being part of one of the largest pharmaceutical supply chains in the world? If you are looking for an exciting career opportunity in supply chain, this could be just the place for you. We...

  • Mechanical Design Engineer

    1 month ago

    Helsingborg, Sweden aira Full time

    Clean-energy tech leads to a positive global transformation. Heating homes contribute to 15% of Europe's CO2 emissions. Switching to sustainable solutions offers households a way to achieve net-zero emissions. Aira's mission is to advance the next generation of home energy solutions, creating intelligent, sustainable homes with a meaningful impact. Starting...

  • Mechanical Design Engineer

    4 weeks ago

    Helsingborg, Sweden aira Full time

    Clean-energy tech leads to a positive global transformation. Heating homes contribute to 15% of Europe's CO2 emissions. Switching to sustainable solutions offers households a way to achieve net-zero emissions. Aira's mission is to advance the next generation of home energy solutions, creating intelligent, sustainable homes with a meaningful impact. Starting...