Resultados de la búsqueda: 31 vacantes
...as we expand the reach of this product into other geographies and with different indications. With adequate supervision, the Regulatory Affairs Specialist II is responsible for ensuring continued compliance with regulatory agency approvals through change assessments. The...
....
Manage and/or participate on quality improvement projects including collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs.
Support cost savings projects. Use of statistical tools to perform analysis and data trending.
Perform...
...the technical/educational level of the end user. Collaborates with other functions (R&D, Design Assurance, Clinical, Medical, Regulatory Affairs, etc.) to ensure Labeling content is developed per, and compliant to, all applicable procedures, standards, and regulations....
...procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Engineering manages... ...drive changes where needed.
Support Regulatory, Medical Affairs, Research and development, Manufacturing, Supplier, Audit,...
...manufacturing processes
GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs
Ability to specify & qualify Assembly, Tooling, Gage equipment and Fixture equipment
Knowledge in the areas of...
...as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations and other regulatory requirements....
Talent Advisors
Alajuela
20 días atrás
...and their impact on the organisation and 'business as usual' activities and processes. Significant inputs into the plan are:
Regulatory requirements
Exceptions / identified control breakdowns
Fraud Risk
External trends / input from leading accounting firms...
...Excellent verbal and written communication skills
implementations or Support environments
Good understanding of statutory and regulatory reporting and process requirements
Ability to handle conflicting priorities
Additional Information
This is a...
...Include:
May execute the following resposibilities:
Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
Consistently generates...
...Experiencia de al menos dos años como microbiólogo o biotecnólogo en industria médica.
Habilidades para redacción clara de documentos regulatorios y reportes.
Experiencia en administración de proyectos.
Additional Information
AbbVie is committed to...
...better and achieve engineering excellence.
Partner with other teams including marketing, systems engineering, QA, hardware and regulatory to understand requirements and bring the best solutions forward.
Minimum Requirements:
~ Bachelor or Master’s degree in...
...government and industry quality assurance standards.
• Develop internal audits to ensure compliance with applicable standards/regulatory requirements and organizations and ISO.
• All other duties as assigned.
• Supervision of quality technicians
•...
...to gather business requirements and translate these into epics and stories on the product backlog.
Adhere to all company and regulatory policies and standards and ensure information is handled securely at all times.
Qualifications
You are comfortable in...
...projects/programs and/or operations.
-Monitor and ensure compliance with company policies and procedures (e.g., federal/country, and regulatory requirements).
What We’re Looking For:
-Licentiate degree in Mechanical, Electromechanical, Electronic, Biomedical, Chemistry,...
...Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Sterility Assurance performs specialized technical and scientific laboratory testing to ensure...
...where you can do your best work.
Purpose of the Position
This position will work with the Direct Tax and local accounting regulatory (Statutory) compliance for all the Baxter legal entities in Costa Rica.
Job Responsibilities:
Prepare, calculate,...
...Develop or update comprehensive DR strategies by recommending specific tools strategies, and solutions that meet internal or regulatory requirements.
Keep up to date with emerging technologies and recommend business directions based on these technologies.
Educate...
...responsible for working cross-functionally to ensure maintenance and review of events and complaints, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product...
...Equipos Médicos.
• GMP (Buenas Prácticas de Manufactura) e ISO (Organización Internacional de Normalización) 9000 y asuntos regulatorios
• Capacidad para especificar y calificar equipos de montaje, herramientas, equipos de medición y accesorios.
• Conocimientos...
...specifications.
Responsible for engineering documentation.
Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
May train and/or provide work direction to technicians...
