Search Results: 31 vacancies
$90k - $130k
...oversight activities for analysis of clinical trial data, ensuring quality and timeliness; prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; perform statistical...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
$150k - $250k
...understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO).
Actively engaged in major industry associations (e.g. CPC, EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Worldwide
$100k - $150k
...in compliance with Health Authority requirements; Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments. Up to 20% remote work allowed...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
...collection, including donor set-up, donor monitoring and donor disconnect.
2 In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process.
3 Evaluates vein performance of the donor to identify...
Suggested
Holiday work
Full time
Temporary work
Immediate start
...analytical experience may be considered in lieu of related degree.
4+ years chemical laboratory / analytical experience preferably in an FDA regulated industry.
2+ years Professional experience with analytical instruments such as HPLC, GC, FTIR, UV/VIS Spectroscopy.
2...
Suggested
Holiday work
Work visa
...supplier quality issues. Includes investigation, resolution, follow-up and corrective actions.
•Initiate and/or maintain the facility FDA or ROW health agency registration and product listing as applicable including UDI maintenance.
Qualifications:
(Education,...
Suggested
Work experience placement
...troubleshoot Vitros 350, FS 5,1, 3400XT, and 4600 analyzers.
Careful attention to detail and accuracy of work are required.
As an FDA regulated facility, documentation is key to this position in order to meet regulatory requirements; therefore, candidate must have...
Suggested
Hourly pay
Contract work
Worldwide
Shift work
Monday to Friday
...Minimum 3 years in either a manufacturing environment, or equipment and packaging technology
Experience in a regulated environment (FDA) a plus
Hands on experience with small molecule solids and liquids manufacturing equipment a benefit
Experience in sterile...
Suggested
Hourly pay
...while minimizing scrap and eliminating customer returns.
Verifies that all appropriate instructions are in place to meet customer, FDA and/or other outside agencies requirements.
Supports CFA Level III and Quality Layout Technicians by creating and explaining...
Suggested
...staff training, readings, sterility checks, reconciliation.
Ensure theapplication of procedures according to the standards described (FDA Guidance, GMP,etc.) and carry out sterility identifications and tests on time
Equipment& Instrument Management
Monitor the...
Suggested
Hourly pay
Contract work
For subcontractor
...seminars.
Your profile
Bachelor’s Degree in Chemistry, Biology, Pharmacy or related field.
Minimum of 2-5 years’ experience in FDA regulated environment, preferably in a pharmaceutical manufacturing setting.
QA/compliance experience in manufacturing, facility...
Suggested
Hourly pay
Immediate start
...administrative documentation, support materials and training.
* Supports CTM/Sr. CTM and clinical operations team to ensure compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all clinical...
Suggested
Holiday work
Work visa
...equivalent business experience
3 + years in import compliance related job responsibilities
Demonstrated knowledge of US Customs and FDA import regulations
Strong interpersonal skills with the ability to work with others in a positive and effective manner in a global...
Suggested
Work visa
...BA/BS in a technical or business related field preferred.
+ 5+ years manufacturing supervisory experience required. Experience in FDA/ISO regulated (Medical Device) industry preferred.
+ Ability to lead production employees in the concept of continuous improvement...
Suggested
Work visa
Night shift
...other related discipline with 3-5 years of experience or Master's degree with at least 1 year of experience.
Experience working in an FDA Medical Device Engineering Facility with associated FDA and ISO regulations is preferred.
Experience with design process from...
Suggested
Holiday work
Flexible hours
...of warranty claims and schedules repair resources
* Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic or international requirements
* Maintain a professional...
For contractors
...analyses, identity potential issues, propose and implement solutions.
Ability to comply with SOP's, cGMP's, HS&E requirements, and FDA, DEA, and OSHA regulations.
Ability to work independently or within a group project team setting.
Computer Skills:
Basic...
Hourly pay
Contract work
For subcontractor
...Performs work in accordance with all applicable local, state, and federal codes and regulations. This includes compliance with OSHA, USDA, FDA, UBC codes, SQF, and ISO regulations and programs as applicable.
Manage maintenance labor, materials, and projects through the...
For contractors
Work experience placement
Local area
Outdoor
...devices, and food products. Regulatory experience with the Consumer Product Safety Commission (CPSC) or the Food and Drug Administration (FDA) is a significant advantage. This position is vital to our succession planning, as some of our senior attorneys are nearing...
...Demonstrated leadership and people management experience; proven ability to motivate a team
Knowledge of food safety regulations (e.g., FDA, USDA) and HACCP principles
Proven leadership, management, and people development skills
Excellent communication and...
Outdoor
Shift work
Weekend work
