Senior Quality Assurance and Regulatory Affairs Manager
hace 2 semanas
Job Summary:
Mcr International is seeking a highly skilled Senior Quality Assurance and Regulatory Affairs Manager to join our team. As a key member of our Quality Assurance and Regulatory Affairs department, you will be responsible for ensuring the company's compliance with regulatory requirements and maintaining a robust quality management system.
Key Responsibilities:
- Participate in the implementation of a total quality culture in the company, ensuring full compliance with MDR, ISO 13485, and 9001 requirements.
- Maintenance and improvement of QMS, including SOP and WI development.
- Lead general regulatory audits and approval submissions.
- Drive internal and supplier audits.
- Coordinate and manage management meeting reviews, including the maintenance of QA metrics (KPIs).
- Management and monitoring of non-conformities and CAPAs.
- Management of QMS SW validations.
- Management, design, and performance of QA training.
- Support in the management of the budget of the Quality department.
- Support the Engineering and Manufacturing department in Quality and Regulatory Aspects of operations management – Management of DCOs (Document Change Orders).
- Management of suppliers' evaluation.
Regulatory Assurance – Requirements:
- Maintenance of Regulatory Environment.
- Participate in the preliminary work for FDA, CE, and other medical approval processes in collaboration with agents, approval bodies, and consultants/CROs.
- Participate in the documentation for regulatory approval bodies and consultants.
- Coordinate Risk Assessment and Analysis throughout QMS and Product Development/Manufacturing.
- Support V&V activities.
- Support Clinical Investigations Submission to NCA and ECs.
Requirements:
- Experience in the Healthcare Sector (>3/5 years).
- Trainee experience in Quality Assurance, Quality Control.
- Thorough knowledge of ISO 13485:2016, ISO 9001:2015, and relevant Medical ISO standards, MDR, along US-FDA Regulations.
- Knowledge in GMP, GLP, GDP.
- Industrial Engineering, Science, or Medical Device Technology Degree.
- English (ALTE-4 or higher).
- Prior experience in the medical device industry.
- Certified Quality Auditor (preferably).
Reporting Line: Head of QA and VP Regulatory and Clinical Affairs
-
Quality Assurance and Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España Mcr International A tiempo completoQuality Assurance and Regulatory Affairs ManagerMADRIDQuality Assurance- Requirements:As a Quality Assurance and Regulatory Affairs Manager at Mcr International, you will participate in the implementation of a total quality culture in the company, ensuring full company compliance with MDR, ISO 13485, and 9001 requirements, and internal quality manuals,...
-
Quality Assurance and Regulatory Affairs Manager
hace 3 semanas
Madrid, Madrid, España Mcr International A tiempo completoJob Title: Quality Assurance and Regulatory Affairs ManagerMcr International is seeking a highly skilled Quality Assurance and Regulatory Affairs Manager to join our team in Madrid. As a key member of our Quality Assurance department, you will be responsible for ensuring the company's compliance with MDR, ISO 13485, and 9001 requirements.Key...
-
Quality Assurance and Regulatory Specialist
hace 1 semana
Madrid, Madrid, España Mcr International A tiempo completoJob SummaryMcR International is seeking a highly skilled Quality Assurance and Regulatory Affairs Specialist to join our team in Madrid. The successful candidate will be responsible for implementing a total quality culture within the company, ensuring compliance with MDR, ISO 13485, and 9001 requirements. This role will also involve maintenance and...
-
Senior Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España Innovaderm Research A tiempo completoJob SummaryThe Senior Regulatory Affairs Manager will oversee the Regulatory Affairs group in assigned regions, ensuring services are conducted according to Innovaderm's standard operating procedures, applicable regulations, and good clinical practices. This role requires leadership on regulatory activities, planning, and assigning work, overseeing direct...
-
Senior Regulatory Affairs Manager
hace 2 meses
Madrid, Madrid, España Innovaderm Research A tiempo completoAbout the RoleWe are seeking a highly experienced and skilled Senior Regulatory Affairs Manager to join our team at Innovaderm Research. As a key member of our Regulatory Affairs department, you will be responsible for leading and managing regulatory activities across various regions, ensuring compliance with applicable regulations and good clinical...
-
Senior Regulatory Affairs Manager
hace 2 meses
Madrid, Madrid, España Innovaderm Research A tiempo completoAbout the RoleWe are seeking a highly experienced and skilled Senior Regulatory Affairs Manager to join our team at Innovaderm Research. As a key member of our Regulatory Affairs department, you will be responsible for leading and managing regulatory activities across various regions, ensuring compliance with applicable regulations and good clinical...
-
Senior Quality Assurance Manager
hace 7 días
Madrid, Madrid, España Https:Www.Pcrecruiter.NetSitemap A tiempo completoJob Title: Senior Quality Assurance ManagerJob Summary:We are seeking a highly experienced Senior Quality Assurance Manager to join our team at PCRecruiter. The successful candidate will be responsible for implementing a total quality culture in the company, ensuring full compliance with MDR, ISO 13485, and 9001 requirements.Key Responsibilities:Participate...
-
Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Parexel A tiempo completoAbout the Role:We are seeking a highly skilled CMC Regulatory Manager to join our team at Parexel. As a key member of our regulatory affairs team, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.Key Responsibilities:Develop...
-
Regulatory Affairs Expert
hace 2 semanas
Madrid, Madrid, España Parexel A tiempo completoUnlock Your Potential in Regulatory AffairsWe are seeking a highly experienced Senior Regulatory Affairs Manager/Consultant to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for managing client relationships, developing regulatory strategies, and ensuring compliance with EU guidelines.Key...
-
Senior Quality Assurance Specialist
hace 5 días
Madrid, Madrid, España Https:Www.Pcrecruiter.NetSitemap A tiempo completoJob Summary: We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at PC Recruiter. As a key member of our Quality Assurance department, you will be responsible for implementing a total quality culture within the company, ensuring compliance with MDR, ISO 13485, and 9001 requirements.Key Responsibilities:Maintenance and...
-
Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoRegulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable...
-
Regulatory Affairs Manager
hace 20 horas
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoAbout the Role:This position is responsible for providing regulatory guidance throughout the clinical development life cycle, compiling and reviewing applications to Regulatory Authorities, and developing documents intended for submission to ensure compliance with regulatory standards.Key Responsibilities:Provide regulatory strategy and development guidance...
-
Regulatory Affairs Specialist
hace 7 días
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoRegulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with applicable...
-
Senior Regulatory Affairs Manager
hace 2 días
Madrid, Madrid, España Qiagen A tiempo completoAbout the Role:The Regulatory Affairs team at QIAGEN is seeking a qualified professional to take on a management role, alongside a Senior Manager. The ideal candidate will have experience in a regulated industry, with participation in Regulatory Affairs activities preparing FDA submissions and EU Technical Documentation.Key Responsibilities:Regulatory...
-
Regulatory Affairs Specialist
hace 5 días
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoRegulatory Manager Job DescriptionWe are seeking a highly skilled Regulatory Manager to join our team at Precision for Medicine (CRO). The successful candidate will provide regulatory strategy and development guidance for optimal conduct of clinical trials, ensuring timely preparation of well-organized, quality regulatory submissions in compliance with...
-
Regulatory Affairs Expert
hace 4 días
Madrid, Madrid, España Sobi Group A tiempo completoKey Responsibilities and Accountabilities:Global Regulatory LeadershipThe Global Regulatory Affairs Lead provides global regulatory leadership of assigned programs, developing global regulatory strategies, including risk assessment and mitigation strategies. This role chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s) and is the...
-
Senior Quality Assurance Specialist
hace 2 semanas
Madrid, Madrid, España Takeda Pharmaceutical A tiempo completoJob Title: Senior Quality Assurance SpecialistAbout the Role:As a Senior Quality Assurance Specialist at Takeda Pharmaceutical, you will be responsible for ensuring the quality of our products and processes. This includes implementing and maintaining a quality management system that meets local and international regulations, as well as ensuring compliance...
-
Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Tbwa ChiatDay Inc A tiempo completoRegulatory Manager Job DescriptionThe Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures. This role ensures timely preparation of well-organized, quality regulatory submissions in compliance with...
-
Regulatory Affairs Specialist
hace 3 semanas
Madrid, Madrid, España Straumann A tiempo completoAbout StraumannStraumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Our company has a proud history of pioneering innovations and advancing dental regeneration, restoration, and replacement. We partner with passionate individuals who share our vision and values.About the RoleWe are seeking a highly skilled...
-
Regulatory Affairs Specialist
hace 3 semanas
Madrid, Madrid, España Straumann A tiempo completoAbout StraumannStraumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Our company has a proud history of pioneering innovations and advancing dental regeneration, restoration, and replacement. We partner with passionate individuals who share our vision and values.About the RoleWe are seeking a highly skilled...