
Regulatory Affairs Specialist
1 day ago
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 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 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, it fits your experience, and you want to join a company that has an interesting journey ahead, we would love to hear from you. We are a value driven organisation, and we expect you to share our passion to make an impact by making lives better for patients worldwide. Therefore we also look to find a person who not only fits the qualifications but also shares our values and fits our organisation personality wise.
In this process we will have a 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 web page: www.maglegroup.com
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