Resultados de la búsqueda: 16 vacantes
...are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
~Regulatory Compliance Analyst
The scope involves providing crucial support to Regulatory affairs team concerning EU MDR certification and...
...are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
~Regulatory Compliance Manager
It will primarily focus on providing specialized support to the regulatory Affairs department regarding EU...
...Insure that all machinery, equipment, tools or any other measuring, monitoring material complies with Corporate, GMP and other regulatory requirements.
Assist in the development / certification of the TIQ’s.
Responsible for conducting EHS inspections to identify...
...and international regulations which govern the user's applications.
Reports on the status of validation activities to fulfill regulatory requirements. Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability...
...standard operating procedures) under appropriate federal regulations.
Reports on the status of validation activities to fulfill regulatory requirements.
Performs investigation non-conformance events
Identify Corrective/Preventive Actions
Implementing...
...LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website qrcgroup.com / to learn more about our services and solutions!
Job Description
Industrial...
...documentation necessary to assure compliance according to the regulation.
~ Reports on the status of validation activities to fulfill regulatory requirements.
~ Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the...
...Representative will play a critical role in maintaining and organizing documents, tracking revisions, and ensuring compliance with regulatory requirements.Responsibilities:
~Manage the document control process, including document creation, review, approval, distribution...
...The Permitting Specialist will play a key role in obtaining necessary permits and approvals and facilitating communication with regulatory agencies.Responsibilities:
~Research and understand regulatory requirements and permitting processes for projects in various jurisdictions...
...and collaboration.
Review project plans, specifications, and drawings to identify potential issues and ensure compliance with regulatory requirements and industry standards.
Monitor project progress and performance against established goals and objectives, proactively...
...Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
~Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
~Experience in Design Documentation (URS, DS...
...cycle protocols.
~Ability to effectively present information and respond to questions from managers, customers, and government regulatory officials.
~Intermediate skill in the use of Excel, Word and PowerPoint.
Experience:
~Minimum of 3-5 years of experience in...
...Sterilization Specialist will ensure that all sterilization and work environment processes are in accordance with company guidelines and regulatory requirements. They must l have a strong, working understanding of sterilization within the medical device industry and related...
...duties as assigned.
REQUIREMENTS:
Refrigeration Licence
Minimum of 7 years of previous experience working in a relative environment in regulatory industry.
Availability to work different shifts on a 24/7 working schedule.
Valid PR driver’s license....
...and project leadership.
~Develop test method qualification and validation protocols.
~Ensure validation master plans comply with regulatory agency requirements.
~Support regulatory submissions and regulatory agency inspections as required.
Qualifications:
~...
...Investigate accidents, incidents, and near-misses, and implement corrective actions to prevent reoccurrence.
~ Coordinate with regulatory agencies and stakeholders on HSE matters, and ensure that all permits and licenses are in place and up-to-date.
~ Provide...
