Average salary: $85,255 /yearly
More stats ...Job Title
Principal Regulatory Affairs Specialist
Job Description
Principal Regulatory Affairs Specialist (U.S. Hub based)
Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product...
Regulatory
Local area
Remote job
Worldwide
Relocation
Work visa
...international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit .
Verathon is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in Bothell, WA. This is a site-based role.
The...
Regulatory
Holiday work
Full time
Local area
Job Description
Job Description Responsibilities and Duties:
· Ensuring organizational and business processes comply with current code and regulations:
OSHA/WISHA
NFPA 99 / 1989 / 55
PC/UPC
EEOC
Title 21 CFR
CGAM-1
FGI
· Identify risks assessments...
Regulatory
Local area
$50 per hour
...predetermined schedule.
• Maintain a clean and safe environment within your vehicle.
• Adhere to all HopSkipDrive policies and regulatory requirements. CareDriver Qualifications
To qualify, you must meet the following criteria:
• Have 5 or more years of...
Regulatory
Full time
Temporary work
Part time
...related patient care activities are delivered in accordance with Emergency Medical Treatment and Labor Act (EMTALA) and associated regulatory requirements.
Adhere to the Nursing department and Hospital’s standards of nursing practice and standards of patient care....
Regulatory
Immediate start
Shift work
...include, but may not be limited to the following:
Electrical, Software, Systems, Experience Design, Design Transfer, Quality, Regulatory
Responsible for reverse engineering and detailed design of legacy PCBA and electrical components and subsystems...
Regulatory
Contract work
...organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.
The?Regulatory Coordinator II?is part of our central team providing regulatory support to Principal Investigators (PIs) and research study teams...
Regulatory
Holiday work
Local area
Flexible hours
...interpret financial reports and general business documents
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
Strong written communication skills are required for preparing or assisting in...
Regulatory
Holiday work
Contract work
Temporary work
...medical device company, recognizing the game-changing innovation we bring to lung disease treatment.
Position Summary : The Regulatory Affairs Specialist will work closely with our Senior Director of RA/QA and Executive management team to support clinical studies...
Regulatory
Holiday work
Work experience placement
..." Track in flight document workflows and provide status updates as required.
" Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
" Provide communication...
Regulatory
...determine root cause, corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated...
Regulatory
Weekly pay
Work experience placement
Shift work
...study Investigators and study documentation.
Oversee and support the creation of the Purchase Orders (PO), trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation.
Continuously improving...
Regulatory
Relocation
Work visa
...rejected materials flows efficiently to prevent material backlog.
* Interface directly with internal and external customers and regulatory agencies as required.
* Support Quality Metrics development and monitoring, participating in regular business and quality...
Regulatory
Holiday work
Flexible hours
...coordination for the strategic implementation of licensing and accreditation programs consistent with state and federal rules and regulatory requirements. An incumbent assures all facets of licensing and accreditation are identified and coordinated into a comprehensive...
Regulatory
...Benefits Technician provides administrative support associated with participant and Fund data in accordance with Company policies, regulatory requirements, and Plan guidelines.
"Has minimum necessary access to Protected Health Information (PHI) and Personally...
Regulatory
Work experience placement
Local area
...strongly desired.
Skills and Abilities:
Must be able to multi-task effectively.
Must be able to follow corporate and regulatory standards.
Must have Excellent oral and written communication skills.
Ability to use lab equipment for debugging purposes is...
Regulatory
Holiday work
...products/applications, including design traceability and verification and validation plans.
•Experience with IEC 60601 or similar regulatory standards or design in a regulated environment (SEMI, MIL-STD, FAA) which requires fulfilling quality systems regulations in the...
Regulatory
Holiday work
Temporary work
Flexible hours
...Flexible Benefits Rep 2 administers flexible benefits for assigned clients in accordance with Company guidelines, client needs, and regulatory requirements.
"Has minimum necessary access to Protected Health Information (PHI) and Personally Identifiable Information (PII)...
Regulatory
Local area
Flexible hours
...and grow WestLand's environmental presence throughout the Pacific Northwest. You will have established relationships with local regulatory agencies, you will already have clientele in the area that you can engage with, and you are comfortable building connections with...
Regulatory
Full time
Local area
Remote job
Flexible hours
...organization. The individual ensures consistent implementation, improvement, and compliance to the NanoString Quality System and global regulatory requirements including, but not limited to; the FDA Quality System Regulation (QSR), Canadian Medical Device Regulatory (CMDR),...
Regulatory
Holiday work
For contractors
...as a subject matter expert for Health Authority inspections and internal audits
Provide support in authoring CMC sections of regulatory submissions
Collaborate with peers within analytical, process development, quality and regulatory to support establishment...
Regulatory
Holiday work
Temporary work
Immediate start
...hand, ordering, and receiving parts
Represent F&E as a Subject Matter Expert (SME) on asset and maintenance management during regulatory inspections
Maintain current state of training with cGMP SOPs
Performs other related duties as assigned by Facilities and Engineering...
Regulatory
Holiday work
Temporary work
For contractors
For subcontractor
Interim role
Immediate start
Outdoor
...more clinical trials. Oversee set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages for Sponsor oversight of CRO and site activitiesEnsure study regulatory files are collected, inventoried, and...
Regulatory
Holiday work
Interim role
Local area
Remote job
Flexible hours
...Disease Division (VIDD). The program supports the research of more than 20 Principal Investigators (PIs).
Responsibilities
The Regulatory Affairs Associate ensures proper oversight of investigator-initiated clinical research and lab-based studies. The Regulatory...
Regulatory
Holiday work
Local area
Remote job
Flexible hours
...necessary.
Strong cross-functional business acumen, including technical, marketing, manufacturing, finance, quality, clinical, and regulatory-based knowledge.
Developing and managing project plans, including scheduling, resourcing, budgeting, and communication, to...
Regulatory
Contract work
Relocation
Work visa
...independently.
# Strong communication skills both verbal and written.
# Interest in learning ISO and/or FDA regulations and regulatory requirements.
# Ability to operate efficiently and effectively in a fast-paced environment.
# Enjoys occasional focused and collaborative...
Regulatory
Immediate start
...years of construction and/or environmental experience at the management level required
~ Knowledge and experience working with Regulatory Agencies such as, OSHA, EPA, DOT and others as appropriate
~ Requires broad theoretical job knowledge typically obtained through...
Regulatory
Full time
For subcontractor
Second job
Local area
Immediate start
Flexible hours
...Familiarity of process automation and business quality systems and software
• Ensure work executed in compliance with company and regulatory quality policy and systems
• Familiar with biotechnology industry and biopharmaceutical manufacturing is preferred
• 0-2...
Regulatory
Flexible hours
Shift work
Monday to Friday
...sponsored banks; act as liaison between clients/brands with sponsored banks.
•Provide clients/brands with compliance-as-a-service and regulatory-as-a-service deliverables, including guidance and support related to BSA/AML matters (i.e., queue exception review and regulatory...
Regulatory
Shift work
...departments to finalize time-sensitive deliverables
•Possess project management skills.
•Strong knowledge of cGMP and domestic regulatory requirements
•Must complete tasks independently, notify manager of decisions outside of established processes and the ability...
Regulatory
Hourly pay
Full time
Contract work
Temporary work
Work experience placement
Immediate start
Worldwide
Flexible hours