Regulatory Affairs Specialist
2 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Adxto AB. In this consulting assignment, you will play a pivotal role in ensuring regulatory compliance within the medical device and pharmaceutical industry.
Key Responsibilities:- Collaborate with cross-functional teams to gather regulatory intelligence and facilitate transition of Legal Manufacturer status for compliance purposes.
- Compile and manage registration dossiers for multiple countries, coordinating with distributors until submission.
- Handle legalization and apostille processes for regulatory submissions, assisting in drafting documents for non-EU markets.
- Manage artwork requests to ensure compliance with regulatory updates, verifying and updating compliance-related information.
- Ensure SPOR/PMS product master data cleansing, verifying and updating compliance-related information, completing missing data ahead of regulatory deadlines.
- Draft SPOR SOPs and support regulatory data clean-up initiatives, verifying and compiling product master data for regulatory databases.
You will be working in a dynamic and supportive environment, driving compliance and innovation in a rapidly evolving industry. The ideal candidate will have proven experience in Regulatory Affairs within Medical Devices and/or Pharmaceuticals.
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Regulatory Affairs Specialist
4 days ago
Stockholm, Stockholm, Sweden Vipas Full timeAbout the RoleVipas AB is looking for a Regulatory Affairs Specialist to join our team and work on exciting projects in the food safety sector. As a key member of our team, you will be responsible for reviewing and approving suppliers' documents related to applicable food safety legislation.Responsibilities:Evaluate suppliers' compliance with food safety...
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Regulatory Affairs Specialist
3 days ago
Stockholm, Stockholm, Sweden POC Full timeAs a Regulatory Affairs Specialist at POC, you'll be part of a dynamic team dedicated to creating safer, more sustainable products. Your primary focus will be on ensuring regulatory compliance and sustainability across our supply chain, product development, and design processes.You'll work closely with internal teams to develop and implement company-wide...
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Regulatory Affairs Specialist
5 days ago
Stockholm, Stockholm, Sweden Galderma Full timeGalderma, the emerging pure-play dermatology category leader, is present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology.We are seeking...
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Regulatory Affairs Consultant
3 days ago
Stockholm, Stockholm, Sweden Adxto AB Full timeReady to make an impact in regulatory affairs?We are looking for a Regulatory Affairs Consultant for a consulting assignment with a client in the medical device and pharmaceutical industry. The consultant will play a key role in regulatory project clean-up and master data management, ensuring compliance with evolving regulations and supporting regulatory...
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Regulatory Affairs Director
3 days ago
Stockholm, Stockholm, Sweden Karo Healthcare Full timeJob OverviewKaro Healthcare, a dynamic and rapidly growing company, is at the forefront of making informed health decisions for everyday healthcare. With an extensive portfolio across multiple categories, including medical products, we own and sell over 80 brands in approximately 90 countries. Our core mission is to empower individuals with smart choices for...
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Regulatory Affairs Lead
4 days ago
Stockholm, Stockholm, Sweden Einride Full timeEinride is shaping the future of transportation by harnessing cutting-edge technologies. As a key member of our Regulatory Affairs and Autonomous Vehicle Safety team, you will develop and execute Einride's regulatory strategy, positioning us as a leader in autonomous freight technologies.Key Responsibilities:Shape the future of mobility regulation by...
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Regulatory Affairs Manager
5 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeTN Sweden is looking for a Regulatory Affairs Manager to lead our regulatory efforts in the food industry. This role requires strong leadership skills and the ability to analyze complex data.Job Description:Lead regulatory efforts to ensure compliance with food safety legislationDevelop ways to process, preserve, and package food safelyAnalyze compliance to...
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Expert in Nuclear Regulatory Affairs
12 hours ago
Stockholm, Stockholm, Sweden NTU International AS Full timeWe are seeking an experienced expert in nuclear regulatory affairs to join our team at NTU International A/S. The successful candidate will play a key role in supporting the implementation of the EU funded project: Strengthening Egyptian nuclear safety and radioprotection regulatory infrastructure.The ideal candidate will have a strong background in nuclear...
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Regulatory Specialist
5 days ago
Stockholm, Stockholm, Sweden Qrios Minds AB Full timeQrios Life Science söker en Regulatory Specialist för ett uppdrag hos ett väletablerat företag inom läkemedelsbranschen. Du kommer att vara ansvarig för regulatoriska frågor och farmakovigilans.FörutsättningarRollen är placerad i Stockholm med nära samarbete med flera funktioner och myndigheter. Uppdraget pågår på heltid från starten och...
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Clinical Affairs Director
4 days ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timeJob Description:Clinical Affairs Specialist plays a key role in the success of our Critical Care business area. We are seeking a highly skilled and experienced individual to join our corporate Medical Affairs team on a 1-year parental cover contract, with the potential for extension.This position involves working closely with the design and coordination of...
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Regulatory Affairs Manager
7 days ago
Stockholm, Stockholm, Sweden Vipas Full timeBecome a regulatory expert at VIPAS AB as a Food Safety & Compliance Specialist. You will review and approve supplier documents related to applicable food safety legislation and materials and parts in contact with food.We are seeking a highly skilled professional who can develop ways to process, preserve, and package food safely and analyze compliance to...
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Director Medical Affairs
3 days ago
Stockholm, Stockholm, Sweden Thor Companies Full timeAs the Director of Medical Affairs, reporting to the VP of Medical Affairs, you will play a key role in shaping strategic and tactical leadership for medical affairs in the region. You will collaborate with key opinion leaders (KOLs), physicians, and healthcare professionals (HCPs) to facilitate scientific discussions, support trial enrolment, and deliver...
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Healthcare Regulatory Expert
3 days ago
Stockholm, Stockholm, Sweden Karo Healthcare Full timeJob DescriptionThe Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs will be responsible for leading the Submissions & Compliance group and overseeing their development. The successful candidate will also develop and implement strategies for submission planning and performance improvement, collaborate with stakeholders, and maintain...
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Regulatory Affairs Specialist
4 days ago
Stockholm, Stockholm, Sweden Kambi Full timeOverviewKambi is seeking a highly skilled Compliance Manager to join our team. As a key member of our organization, you will play a critical role in ensuring the effective operation of our business.The Compliance Manager will be responsible for implementing and maintaining effective internal controls, monitoring regulatory changes, and ensuring compliance...
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Regulatory & Pharmacovigilance Specialist
1 week ago
Stockholm, Stockholm, Sweden QRIOS AB Full timeQRIOS Life Science söker en Regulatory & Pharmacovigilance Specialist för ett uppdrag hos ett väletablerat företag inom läkemedelsbranschen. Du kommer att vara ansvarig för regulatoriska frågor och farmakovigilans och rollen kombinerar både operativa och strategiska arbetsuppgifter, med nära samarbete med flera funktioner och myndigheter. Uppdraget...
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Director of Medical and Scientific Affairs
4 days ago
Stockholm, Stockholm, Sweden Nordberg Medical Full timeWe're a global company dedicated to innovation and improving lives.The Head of Medical Affairs Nordics will play a key role in driving business growth by establishing strategic and tactical leadership in their region.This position requires a strong understanding of combination product development, regulatory processes, and excellent communication skills in...
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Future Mobility Regulatory Expert
4 days ago
Stockholm, Stockholm, Sweden Einride Full timeWe're looking for a Future Mobility Regulatory Expert to join our Regulatory Affairs and Autonomous Vehicle Safety team at Einride. In this role, you will develop and execute Einride's regulatory strategy, positioning us as a leader in autonomous freight technologies.Your Key Responsibilities:Develop and execute regulatory strategies to ensure compliance...
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Head of Nordic Medical Affairs
4 days ago
Stockholm, Stockholm, Sweden Nordberg Medical Full timeWe're committed to fostering innovation and creativity within our global team.The Head of Medical Affairs Nordics will play a pivotal role in establishing our presence in the Nordic market, working closely with key stakeholders to drive business growth.This position offers a unique chance to make a meaningful impact on our company's success.We value teamwork...
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Nordic Public Affairs Manager
2 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeJob DescriptionAs a Nordic Public Affairs Manager, you will play a critical role in developing and executing our public policy strategy in the Nordics. You will work closely with our operations, product, marketing, and communications teams to ensure that our goals are aligned and our message is effectively communicated to key stakeholders.Key...
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Healthcare Professional Specialist
4 days ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timeKey Responsibilities:The Clinical Affairs Specialist will be responsible for:Working closely with the Critical Care business area to design and coordinate CC sponsored clinical studies;Ensuring timely completion of studies and compliance with regulatory requirements;Managing and executing post-market clinical research studies and surveys;Maintaining...