Regulatory Affairs Specialist

5 days ago

Malmo, Skåne, Sweden Magle Group Full time

Magle Group is growing and we are looking for a Regulatory Affairs Specialist who is seeking a new challenge and wants to be part of a small but dynamic regulatory team. Magle Group supports other Life Science Companies by providing CDMO services as well as developing and manufacturing our own products with DSM technology. This role will focus on supporting our medical devices business and ensuring compliance with all regulatory standards and guidelines applicable in our active markets. The Regulatory Affairs Specialist plays a crucial 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.
  • Stay updated on 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 organization on submission 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 5 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, MDR, 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.
  • Experience with APIs including CEP and ASMF files is a plus.
  • Familiarity with the regulatory landscape in key international markets (e.g., Europe, Asia, and North America).
  • Proficient with regulatory submission software and document management systems.

The position is located in Malmö on-site.

If you find the above position interesting, fit your experience, and want to join a company that has an interesting journey ahead, we would love to hear from you. We are a value-driven organization, and we expect you to share our passion for making an impact by improving lives for patients worldwide. Therefore, we also look to find a person who not only fits the qualifications but also shares our values and aligns with our organizational personality.

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

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