Senior Quality and Regulatory Specialist
Wise Professionals AB / Biomedicinjobb / Malmö
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hela Sverige At Magle Chemoswed, we are dedicated to making a difference by bringing groundbreaking healthcare innovations to patients worldwide. As a Senior Quality and Regulatory Specialist, you will play a crucial role in advancing ideas into real-life products that have a profound impact on people's lives.
KEY RESPONSIBILITIES
Submission, surveillance and maintenance of international product registrations including the preparation, legalization and shipment of regulatory documents
Submit documents and timely responses with international regulatory bodies, in accordance with local and international regulation
Support the project managers in the development of relevant regulatory procedures and work instructions and be involved in all stages of development in all areas (pharmaceutical and medical device) and support with regulatory strategy setting that meet GMP and international ISO or equivalent standards.
Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations and standards.
Coordination of, review, and submission of post mark surveillance and product safety reports.
QUALIFICATIONS
Experienced in the medical device, IVD or pharmaceutical industry including standard regulatory tasks
Ideally have knowledge of requirements in accordance with MDD/MDR, relevant regulations, international standards and guidance documents (MEDDEVs, etc.) and of European cGMP
Excellent English and Swedish communication skills (written and oral)
BS degree in pharmacy or other related natural science - preferred
ABOUT MAGLE CHEMOSWED
Magle Chemoswed was formed in 2017, when Magle Life Sciences acquired Chemoswed. Since the acquisition, we are a CDMO with our own technology platform and product portfolio. The new structure brings synergies by building capacity across the entire value chain. We own our manufacturing and development facilities and we hold all the resources required to manage drug substances and biopharmaceuticals, as well as to develop and manufacture our own medical technology products.
We are lucky to employ around 70 brilliant people of many different nationalities, with diverse backgrounds, and experiences.
For more information, visit our website
https://maglechemoswed.com/APPLICATION PROCESS
Magle Chemoswed and Wise Professionals have teamed up on the recruitment for this role. For any questions regarding the process, please contact Recruitment Consultant, Saba Solomon at
saba.solomon@wise.se. Applications are reviewed on a continuous basis. Therefore, we encourage you to apply as soon as possible as the position may be filled sooner. We are unable to accept applications via regular email. You can simply apply with your CV or LinkedIn profile at
www.wise.se and answer three brief questions. If selected to the next step, you will be directed to further testing.
We choose to evaluate early in the interview process to ensure an objective and non-discriminatory candidate selection.
We look forward to connecting with you.
Ersättning Månadslön - Fast lön
Så ansöker du Sista dag att ansöka är 2023-09-03
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "wiseprofessionals21546".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Wise Professionals AB (org.nr 556761-2865)
Arbetsplats Wise Professionals
Jobbnummer 8008699
Observera att sista ansökningsdag har passerat.