Quality and Regulatory Affairs
hace 5 meses
Overview
Post Date November 7, Number WEBWW-- Job Function QA&RA Location Barcelona, Spain Country Spain
About the Position
ob Summary
The Quality and Regulatory Affairs (QA/RA) Trainee supports the execution of pre
and/or post market regulatory affairs departmental functions, including, but not limited to,
assisting in the preparation of documentation and information required to place and to
keep products on the market: regulatory submissions, licensing and registrations,
assisting in the execution of post market surveillance activities: complaint evaluations,
product corrections, removals and recalls.
Key Accountabilities
Assists in efforts to ensure the company is properly registered and in compliancewith applicable national and international regulations.
Collaborates in efforts to prepare and submit regulatory submittals for marketclearance, licensing, registration and legalization.
Supports the execution of global field corrective actions/recalls. Assists in interactions regarding regulatory affairs with all functional areas of thecompany as required, including senior management, mainly, providing support to the
Tender and Sales departments to comply with customer’s requests, including but not
limited to: Declarations of Conformity/EC Certificates, Instructions for Use and
Labelling, Lot Certificates and Safety Data Sheets.
Ensures correct upload and maintenance up to date in the Information Systems ofthe Company, regarding the documented information of the tasks under his/her
responsibility.
Ensures compliance with Werfen Code of Ethics.Networking/Key relationships
This position may require cooperating with the Tender Office, Sales and Marketing
Office, Service Office, Supply Chain Office, Regulatory contact of represented
companies/manufacturers and customer contacts.
Minimum Knowledge & Experience required for the position
Education: Degree in a science, finance and administration discipline or equivalent
applicable experience.
Experience: Not required. Additional Skills/Knowledge:o Awareness of the requirements of relevant local and international regulations.
o Strong computer skills required: MS Office, ability to use an enterprise
resource planning system (ERP) and other regulatory software tools.
o Language: Spanish and English.
Skills & Capabilities
The ideal candidate for this position will exhibit the following skills andcompetencies:
o Strong willingness to comply with regulations and procedures
o Excellent written and verbal communication skills
o Teamwork and collaboration
o Attention to detail
o Delivers results
o Customer focus
o Relationship management
o Flexibility and adaptability to a fast-changing environment
Start date: January / February
-
Quality Assurance and Regulatory Affairs Manager
hace 4 semanas
Barcelona, Barcelona, España Mcr International A tiempo completoQuality 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 Department, you will be responsible for ensuring full company compliance with MDR, ISO 13485, and 9001 requirements, as well as internal quality manuals,...
-
Quality Assurance and Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Nobel Biocare A tiempo completoJob Title: Quality Assurance and Regulatory Affairs TechnicianThis role is to cover a vacancy at Mimetis Biomaterials, a small medical device company located in Barcelona which is part of Nobel Biocare.The Quality Assurance and Regulatory Affairs Technician is accountable for timely execution of quality activities and regulatory strategies to support launch...
-
Quality Assurance and Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Nobel Biocare A tiempo completoJob Title: Quality Assurance and Regulatory Affairs TechnicianThis role is to cover a vacancy at Mimetis Biomaterials, a small medical device company located in Barcelona which is part of Nobel Biocare.The Quality Assurance and Regulatory Affairs Technician is accountable for timely execution of quality activities and regulatory strategies to support launch...
-
Quality Assurance and Regulatory Affairs Specialist
hace 3 semanas
Barcelona, Barcelona, España Nobel Biocare A tiempo completoJob Summary:Nobel Biocare is seeking a Quality Assurance and Regulatory Affairs Specialist to support the set-up, maintenance, and documentation of the Quality Management System (QMS) for Mimetis Biomaterials products.The successful candidate will be responsible for ensuring the effective implementation of internal procedures and processes, managing QA...
-
Regulatory Affairs Director
hace 3 semanas
Barcelona, Barcelona, España Innovaderm Research A tiempo completoThe Senior Manager, Regulatory Affairs will lead the regional regulatory affairs department at Innovaderm Research, ensuring all services are conducted according to standard operating procedures, applicable regulations, and good clinical practices. Key responsibilities include providing leadership on regulatory activities, planning and assigning work,...
-
Regulatory Affairs Consultant
hace 4 semanas
Barcelona, Barcelona, España Clarivate A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Consultant to join our Clinical and Regulatory Team at Clarivate. As a key member of our team, you will be responsible for delivering regulatory consulting projects and supporting business development initiatives.Key ResponsibilitiesProject Delivery Support (70%): Act as a point of contact for...
-
Regulatory Affairs Consultant
hace 4 semanas
Barcelona, Barcelona, España Clarivate A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Consultant to join our Clinical and Regulatory Team at Clarivate. As a key member of our team, you will be responsible for delivering regulatory consulting projects and supporting business development initiatives.Key ResponsibilitiesProject Delivery Support (70%): Act as a point of contact for...
-
Consultant Ra QA
hace 5 meses
Barcelona, España Clarivate A tiempo completoConsultant RA QA - ( Regulatory Affairs / Quality Assurance ) - Barcelona ( Hybrid ) We are looking for a RAQA Consultant ( Regulatory Affairs / Quality Assurance ) to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory and quality consulting projects. We have a great skill set in data monitoring, content writing and...
-
Trainee Quality
hace 4 semanas
Barcelona, España HARTMANN A tiempo completoEn HARTMANN nos dedicamos a **ayudar**, **cuidar**, **proteger** y **crecer**. Apoyamos a los profesionales de la salud para que puedan centrarse en lo que realmente importa: impactar positivamente en la vida de las personas. Creamos soluciones que marcan la diferencia, y con tu compromiso podrás desarrollarte profesionalmente cada día. En HARTMANN tu...
-
Manager, Regulatory Affairs
hace 1 mes
Barcelona, España Innovaderm Research A tiempo completo.The Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm's standard operating procedures, applicable regulations and good clinical practices and to the Sponsor's satisfaction. Responsibilities include providing leadership on regulatory activities that...
-
Regulatory Affairs Consultant
hace 3 semanas
Barcelona, Barcelona, España Clarivate A tiempo completoJob DescriptionWe are seeking a highly skilled Regulatory Affairs Consultant to join our Clinical and Regulatory Team at Clarivate. As a key member of our team, you will be responsible for delivering high-quality regulatory services to our global clients.Key Responsibilities:Project Delivery Support: Act as a point of contact for customers throughout a...
-
Regulatory Affairs Director
hace 3 semanas
Barcelona, Barcelona, España Innovaderm Research A tiempo completoJob SummaryThe Senior Manager, Regulatory Affairs will lead the regional regulatory affairs department to ensure compliance with Innovaderm's standard operating procedures, applicable regulations, and good clinical practices. Key responsibilities include providing strategic guidance on regulatory activities, overseeing the performance of direct reports, and...
-
Regulatory Affairs Director
hace 2 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Summary:As Regulatory Affairs Associate Director, you will play a pivotal role in driving and delivering high-quality documentation to support successful submissions, ensuring timely and accurate reporting of regulatory activities, and coordinating the preparation and execution of regulatory documents.Key Responsibilities:• Lead, coach, and mentor...
-
Consultant Ra QA
hace 5 meses
Barcelona, España Clarivate A tiempo completoWe are looking for a **RAQA Consultant** **( Regulatory Affairs / Quality Assurance ) **to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory and quality consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains **About You - experience, education, skills,...
-
Regulatory Affairs Director
hace 3 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of associates within the Regulatory API department, driving and delivering high-quality documentation to support successful submissions. Your responsibilities will include leading, coaching, and mentoring associates, ensuring sufficient training and development opportunities to...
-
Regulatory Affairs Associate Director
hace 4 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAs a key member of our Regulatory Affairs team, you will play a critical role in ensuring the success of our regulatory submissions. Your expertise will be essential in driving high-quality documentation and ensuring compliance with global regulatory standards.Key Responsibilities:Lead and mentor a team of...
-
Regulatory Affairs Associate Director
hace 3 semanas
Barcelona, Barcelona, España Sandoz A tiempo completoJob Title: Regulatory Affairs Associate DirectorAs a Regulatory Affairs Associate Director at Sandoz, you will lead a team of regulatory professionals responsible for ensuring the company's compliance with global regulatory standards. Your key responsibilities will include:Leading a team of regulatory associates to drive high-quality documentation and...
-
Manager, Regulatory Affairs
hace 1 mes
Barcelona, España Innovaderm Research A tiempo completoThe Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm's standard operating procedures, applicable regulations and good clinical practices and to the Sponsor's satisfaction.Responsibilities include providing leadership on regulatory activities that...
-
Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Dsm Nutritional Products A tiempo completoRegulatory Affairs Raw Materials TTHDSM Nutritional ProductsJob Summary: We are seeking a highly motivated and detail-oriented individual to join our Raw Materials Team in Regulatory Affairs. As an Apprentice Regulatory Affairs Raw Materials TTHDSM Nutritional Products, you will play a crucial role in performing global compliance assessments, encoding and...
-
Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Dsm Nutritional Products A tiempo completoRegulatory Affairs Raw Materials TTHDSM Nutritional ProductsJob Summary: We are seeking a highly motivated and detail-oriented individual to join our Raw Materials Team in Regulatory Affairs. As an Apprentice Regulatory Affairs Raw Materials TTHDSM Nutritional Products, you will play a crucial role in performing global compliance assessments, encoding and...
