
Regulatory Compliance Expert
10 hours ago
Magle Group is a dynamic and innovative company that provides CDMO services and develops and manufactures products with DSM technology. We are seeking a highly skilled Regulatory Affairs Specialist to join our small but dynamic regulatory team. 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 successful candidate will play a crucial role in the submission, registration, and lifecycle management of our medical device products. Key responsibilities include preparing and submitting regulatory documentation required for approval and registration in various international markets, staying updated on regulatory procedures and changes in the regulatory climate, and ensuring compliance and advising the company on necessary adjustments.
- Key Responsibilities:
- Prepare and submit regulatory documentation for new and existing products in various international markets.
- Stay updated on regulatory procedures and changes in the regulatory climate.
- Ensure compliance and advise the company on necessary adjustments.
- Maintain regulatory files and update regulatory authorizations.
- Respond to questions from regulatory authorities.
- Assess device-related incidents and complaints for medical device reporting 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.
- Proven track record in preparing successful regulatory submissions.
- Excellent communication skills.
-
Regulatory Compliance Specialist
24 hours ago
Malmo, Skåne, Sweden Magle Chemoswed AB Full timeMagle Group is a dynamic and growing company in the Life Science industry, providing CDMO services and developing products with DSM technology. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory standards and guidelines applicable in our active markets.Key Responsibilities:Prepare and submit regulatory...
-
Regulatory Compliance Specialist
7 days ago
Malmo, Skåne, Sweden Magle Chemoswed Full timeIn this role, you will be part of a talented team dedicated to developing and manufacturing innovative therapies. You will have the opportunity to work on complex projects, develop new skills, and contribute to our mission.The QC Manager will lead and inspire our Quality Control team to achieve analytical excellence and compliance. This involves overseeing...
-
Market Compliance Manager Regulatory
5 days ago
Malmo, Skåne, Sweden Oatly Full timeAbout the RoleWe are seeking a highly experienced Regulatory Affairs Market Manager to join our team in Malmö, Sweden. In this role, you will be responsible for ensuring that our products comply with all applicable regulatory requirements across Europe and International Markets.You will work closely with our Innovation, Creatives, and Commercial teams to...
-
International Regulatory Expert
5 days ago
Malmo, Skåne, Sweden Oatly AB Full timeRegulatory Affairs Market Manager Job SummaryWe are seeking a talented Regulatory Affairs Market Manager to join our team. The successful candidate will have a strong background in food regulatory compliance, with experience working in the European market.In this role, you will be responsible for providing day-to-day support to our business, including...
-
Global Regulatory Expert
5 days ago
Malmo, Skåne, Sweden Oatly Full timeWhy Oatly?Oatly is a pioneering company in the plant-based dairy alternative market, with a strong commitment to sustainability and social responsibility. We are dedicated to making it easy for people to turn what they eat and drink into personal moments of healthy joy without recklessly taxing the planet's resources in the process.We are seeking a highly...
-
Regulatory Affairs Market Strategist
5 days ago
Malmo, Skåne, Sweden Oatly Full timeOur Commitment to SustainabilityOatly is a leader in the plant-based dairy alternative market, with a strong focus on sustainability and social responsibility. As a key player in this rapidly growing industry, we are committed to creating a better future for our customers, employees, and the planet.We are seeking a highly skilled Regulatory Affairs Market...
-
Medical Device Regulatory Affairs Manager
20 hours ago
Malmo, Skåne, Sweden Magle Chemoswed AB Full timeMagle Chemoswed AB is expanding its regulatory team and seeking a skilled Regulatory Affairs Specialist to support our medical devices business. As a key member of the team, you will be responsible for ensuring compliance with regulatory standards and guidelines applicable in our active markets.Responsibilities:Develop and implement regulatory strategies to...
-
Regulatory Affairs Specialist
1 day ago
Malmo, Skåne, Sweden Magle Chemoswed AB Full timeMagle Group is growing and we are looking Regulatory Affairs Specialist who is looking for a new challenge and who wants to be part of a small but dynamic regulatory team. Magle Group is supporting other Life Science Companies by providing CDMO services as well developing and manufacturing our own products with DSM technology. This role will focus on...
-
Medical Device Regulatory Expertise
4 hours ago
Malmo, Skåne, Sweden Magle Chemoswed Full timeJob Overview:We are seeking a skilled Regulatory Affairs Specialist to join our regulatory team. In this role, you will be responsible for ensuring compliance with international regulatory standards and guidelines applicable in our active markets.Your key responsibilities will include:Preparing and submitting regulatory documentation required for the...
-
Regulatory Affairs Specialist Position
4 hours ago
Malmo, Skåne, Sweden Magle Chemoswed Full timeJob Description:Magle Chemoswed is a leading provider of Contract Development and Manufacturing Organization (CDMO) services to the Life Science industry. We are seeking a highly skilled Regulatory Affairs Specialist to join our dynamic regulatory team.In this role, you will be responsible for ensuring compliance with international regulatory standards and...
-
Regulatory Affairs Professional
4 hours ago
Malmo, Skåne, Sweden Magle Chemoswed Full timeKey Responsibilities:The Regulatory Affairs Specialist will be responsible for ensuring compliance with international regulatory standards and guidelines applicable in our active markets. The key responsibilities of this position include:Preparing and submitting regulatory documentation required for the approval and registration of new and existing products...
-
Medical Device Regulatory Specialist
10 hours ago
Malmo, Skåne, Sweden Magle Group Full timeWe are Magle Group, a value-driven organization that has an interesting journey ahead. We are looking for a talented Regulatory Affairs Specialist to support our medical devices business and ensure compliance with all regulatory standards and guidelines applicable in our active markets.This role will be responsible for preparing and submitting regulatory...
-
QA Compliance and Projects Manager
3 days ago
Malmo, Skåne, Sweden SEVER Pharma Solutions Full timeAbout SEVER Pharma SolutionsWe are a leading pharmaceutical company dedicated to developing and manufacturing high-quality products that meet regulatory requirements and industry standards.Our team is passionate about delivering exceptional results and making a positive impact on people's lives. We strive to create a work environment that fosters...
-
Regulatory Affairs Market Strategist
5 days ago
Malmo, Skåne, Sweden Oatly AB Full timeWe are seeking a Regulatory Affairs Market Manager to support our Europe & International Markets. The ideal candidate will have a strong background in food regulatory compliance, with experience working in the European market.The successful candidate will be responsible for day-to-day support to our business, revising product composition, labeling, and other...
-
Compliance and Quality Assurance Specialist
4 hours ago
Malmo, Skåne, Sweden Magle Chemoswed Full timeResponsibilities:As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with international regulatory standards and guidelines applicable in our active markets. Your key responsibilities will include:Preparing and submitting regulatory documentation required for the approval and registration of new and existing products in...
-
Oatly Regulatory Affairs Specialist
5 days ago
Malmo, Skåne, Sweden Oatly AB Full timeOatly AB is looking for a Regulatory Affairs Market Manager to join our team. As a key member of our global regulatory affairs function, you will play a critical role in ensuring that our products meet all applicable regulatory requirements across Europe and international markets.Your primary responsibility will be to provide day-to-day support to our...
-
Regulatory Compliance Manager
3 days ago
Malmo, Skåne, Sweden Sever Pharma Solutions Full timeAbout the TeamOur QA department is committed to upholding the highest standards of quality and compliance.We are looking for a motivated and dedicated Quality Assurance Manager to join our team.As a member of our team, you will have opportunities to develop in various areas and drive our success through your unique contributions.We believe in creating a...
-
Malmo, Skåne, Sweden SEVER Pharma Solutions Full timeAbout Our TeamWe are a diverse and dynamic team of professionals dedicated to delivering exceptional results and making a positive impact on people's lives. Our team members share a passion for innovation, collaboration, and continuous learning.As a QA Compliance and Projects Manager, you will have the opportunity to work closely with our cross-functional...
-
Regulatory Compliance Officer
3 days ago
Malmo, Skåne, Sweden SEVER Pharma Solutions Full timeAbout Our CompanyWe at SEVER Pharma Solutions (SPS) strive to develop and manufacture pharmaceuticals and combination products with uncompromising quality.Our goal is to bring pharmaceutical ideas to life by offering expertise in high potent drug development, performance enhancement, and perfection. We aim to provide our customers with unique capabilities...
-
QA Manager Compliance Expert
5 days ago
Malmo, Skåne, Sweden Agardh Consulting Full timeVår vision är att bli ledande inom Life Science-branschen. För att uppnå detta behöver vi en erfaren QA Manager Compliance Expert som kan säkerställa att våra kvalitetsprocesser uppfyller höga krav.I denna roll kommer du att utveckla och integrera kvalitetsarbetet med Rechons huvudprocesser. Du kommer också att genomföra egeninspektioner och...