
Regulatory Affairs Expert
18 hours ago
Key Responsibilities:
- Develop and manage Quality Management System (QMS) processes to ensure compliance with medical device regulations (MDR, ISO 13485, FDA).
- Support management of CAPA, non-conformance, change management, and audits.
- Conduct QA reviews, investigate non-conformance, and manage CAPA.
- Analyze quality data and identify training needs.
- Address Quality Assurance and Regulatory Compliance issues.
- Initiate and lead projects to improve quality assurance processes.
- Coordinate and support on-site audits conducted by external providers.
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Regulatory Affairs Expert
18 hours ago
Stockholm, Stockholm, Sweden Scandinavian Biopharma Full timeScandinavian Biopharma is a research-based specialty biopharma company dedicated to improving people's lives by developing innovative solutions for various health conditions. We are currently seeking an experienced Regulatory Affairs Expert to join our dynamic team.The ideal candidate will have a strong background in regulatory affairs, with a focus on CMC...
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Regulatory Affairs Manager
19 hours ago
Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full timeSenior RA Specialist Med Tech - Life ScienceBondi Chefrekrytering AB is an innovative and international Swedish medtech company with high potential.Purpose of position:Responsible for regulatory strategy, guidance to the organization on regulatory affairs matters throughout the life cycle of a medical device from product development, placing product on the...
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Regulatory Affairs Specialist in Biopharmaceuticals
19 hours ago
Stockholm, Stockholm, Sweden Qrios Minds AB Full timeJob DescriptionQrios Minds AB is seeking a highly experienced Regulatory Affairs Manager to join our team. As a regulatory CMC expert, you will play a crucial role in coordinating the regulatory strategy for the development and implementation of changes in the manufacturing process.Develop and implement regulatory strategies for the development and...
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Regulatory Affairs Specialist
19 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAt TN Sweden, we are seeking a skilled Senior Regulatory Consultant to join our Regulatory Affairs Division. In this role, you will work on projects from various Pharmaceutical companies, handling challenging tasks that require result-oriented and client-focused approaches.The ideal candidate will have a deep understanding of registration procedures and...
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Regulatory Affairs Specialist
19 hours ago
Stockholm, Stockholm, Sweden Karo Group Full timeKaro Group, a leading healthcare company, is committed to empowering people to make informed health decisions.We are currently seeking a highly skilled Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs professional to join our headquarters in Stockholm, Sweden.About the Role:Lead the Submissions & Compliance team and oversee maintenance...
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Nordic Regulatory Affairs Position
18 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeWe are seeking a talented and experienced Senior Regulatory Consultant to join our team at TN Sweden. As a key member of our Regulatory Affairs Division, you will play a crucial role in supporting the development of our clients' pharmaceutical products.The successful candidate will have a strong background in Regulatory Affairs, with a focus on Nordic...
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Regulatory Affairs Director
18 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeJob Overview:The Regulatory Affairs Manager position at TN Sweden presents an exceptional opportunity for a skilled professional to contribute to the company's growth and success in the regulatory landscape.
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Development Lead
19 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeJob DescriptionSenior Manager, Regulatory SciencesWe are seeking an experienced Senior Manager, Regulatory Sciences to join our team in Stockholm. The successful candidate will have a strong background in regulatory affairs and excellent leadership skills.About the CompanyTN Sweden is a leading consultancy specializing in regulatory sciences. We work closely...
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Regulatory Affairs Specialist Electric Vehicle
18 hours ago
Stockholm, Stockholm, Sweden Promote Project Full timeAt Promote Project, we help Scandinavian businesses find and work with top tech talent.We focus on long-term, full-time remote collaborations that drive growth.Job Overview:We are seeking an experienced Regulatory Affairs Specialist to join our team immediately. The ideal candidate will have a strong background in automotive compliance, particularly in...
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Regulatory Affairs Specialist
19 hours ago
Stockholm, Stockholm, Sweden Intertek Semko AB Full timeAs a Junior Regulatory Affairs Specialist at Intertek, you will play a crucial role in supporting clients across Sweden and internationally with their chemical regulation needs.We are seeking a highly motivated individual to join our team of experts in the field of chemical regulations. In this role, you will be responsible for providing regulatory...
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Pharmaceutical Regulatory Expert Senior Position
19 hours ago
Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full timeWe are seeking an accomplished Regulatory Affairs Expert to lead our post-approval/life-cycle regulatory activities in the Nordic markets (Sweden, Norway, Finland, Denmark, Iceland). As part of our EU Regulatory Affairs team, you will be responsible for managing regulatory submissions, maintaining compliance with regulations, and ensuring alignment on...
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Medical Device Regulatory Expert
18 hours ago
Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full timeRA Strategist in Med TechBondi Chefrekrytering AB is seeking a skilled RA Strategist to join their team.The role involves:Developing and implementing regulatory strategies to ensure compliance with laws and regulations.Providing guidance on regulatory affairs matters throughout the life cycle of medical devices.Acting as a Regulatory Affairs Expert with new...
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Regulatory Affairs Director
3 days ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timeJob DescriptionWe are seeking an experienced Senior Director Regulatory Affairs to lead our regulatory strategies and drive compliance across the Nordics.Main Responsibilities:Develop and implement tailored regulatory strategies for OTC products in the Nordic region.Ensure submission packages meet Nordic regulatory standards, eliminating deficiencies prior...
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Director of Regulatory Affairs
18 hours ago
Stockholm, Stockholm, Sweden PharmaRelations ApS Full timePharmaRelations ApS OverviewWe are a leading Sales, Marketing and Distribution company in Sweden with a vision to make brands more successful.Job DescriptionThe Senior Director Regulatory Affairs will take ownership of regulatory activities across various areas, including MAs (MRP/DCP and national licenses), and oversee the marketing of cosmetics, medical...
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Manager Regulatory Affairs Nordic Markets
19 hours ago
Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full timeWe are seeking an experienced Regulatory Affairs Manager to join our team in the Nordic region. As part of our EU Regulatory Affairs team, you will be responsible for providing strategic advice to our cross-functional team on regulatory matters; ensuring alignment on strategies proposed/discussed with the rest of the EU Regulatory Team.Main...
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Regulatory Affairs Manager Nordic Region
18 hours ago
Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full timeWe are seeking a highly motivated and detail-oriented Regulatory Affairs Manager to join our team in the Nordic Region. As part of our EU Regulatory Affairs team, you will be responsible for post-approval/life-cycle regulatory activities in the Nordic markets (Sweden, Norway, Finland, Denmark, Iceland) for our company's Nordic portfolio.Main...
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Regulatory Affairs and Compliance Professional
19 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeKey ResponsibilitiesAs a Compliance Officer, your primary responsibilities will include:Providing guidance on compliance matters to internal stakeholders, including management and staff.Collaborating with the Regional Compliance Team to identify and address compliance gaps.Reviewing and updating internal compliance policies and procedures to ensure alignment...
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Senior Regulatory Specialist
18 hours ago
Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full timeMed Tech Regulatory Compliance SpecialistThis is an excellent opportunity to work with an innovative Swedish medtech company that has high growth potential.The purpose of this role is:To be responsible for regulatory strategy and provide guidance on regulatory affairs matters throughout the life cycle of medical devices.To act as a Regulatory Affairs Expert...
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Regulatory Affairs Specialist
18 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeOverview:As a key member of the Global Regulatory Affairs team, the Global Labeling Operations Lead is responsible for coordinating, managing, and executing activities related to the approval and maintenance of printed labeling components.This role will also support the Global Labeling and Regulatory Strategy teams with various operational labeling...
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Global Regulatory Affairs Lead
19 hours ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAs a key member of our team, you will play a pivotal role in driving the success of our global pharmaceutical products. With a strong background in regulatory affairs, you will be responsible for ensuring compliance with relevant regulations and guidelines.Key Responsibilities:Personnel Management: Supervise and develop the skills of the Submissions &...