Search Results: 344 vacancies
...synthesize and communicate complex information. Capacity to propose practical mitigation (de-risking) strategies. Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations. Required experience in authoring non-clinical elements of major regulatory...
Suggested
For contractors
Flexible hours
...ABILITIES (REQUIRED): Knowledge of relevant governmental regulation (e.g. OMB Uniform Guidance, Cost Accounting Standards, Medicare, FDA, OHRP).Ability to understand and interpret university and sponsor policies. Strong analytical, interpersonal, and written and oral...
Suggested
Full time
Remote job
...safety measures, EXOS requires that all successful applicants at this location shall be required to show proof of full vaccination by an FDA-approved COVID-19 vaccine before beginning employment, unless an exemption from this policy has been granted as an accommodation or...
Suggested
Local area
Worldwide
...engineering/science principals and laboratory skills.
Strong knowledge of defined development process that is consistent with ISO, FDA design control standards or requirements.
Experienced in one or more of the following: Electro-mechanical, software, mathematical,...
Suggested
Local area
Shift work
...schematics and mechanical layouts to support document control and tool release.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive...
Suggested
For contractors
Work experience placement
Local area
Shift work
...deep system level understanding of qPCR.
Work on Sustaining projects
Evaluate optical systems for improvements.
Understand FDA requirements.
The essential requirements of the job include:
Degree in Optics, EE, Physics, Fluidics or related disciplines with...
Suggested
Full time
Immediate start
Remote job
...Good Manufacturing Practices (cGMPs), established cleaning policies and procedures, to maintain compliance with quality standards and FDA regulations. The incumbent plays a critical role in assuring sanitary conditions of the controlled areas are maintained, to allow for...
Suggested
Holiday work
Full time
Local area
Night shift
Weekend work
Day shift
Afternoon shift
...knowledge in clinical research, preferably in analyzing and processing brain signal and image data (fMRI/EEG).
Basic understanding of FDA processes, OHRP, and HIPAA compliance.
Solid experience in coding-related tasks (e.g., Python, Java, MATLAB).
Proactive and...
Suggested
Local area
...exercise judgment within defined procedures and policies to determine and take appropriate action.
Possess a strong knowledge of the FDA,cGMP, andGCP standards as well as regulatory guidance documents such as Annex 13.
Possess clinical supplies experience/...
Suggested
Full time
Contract work
Temporary work
For contractors
Work experience placement
Immediate start
Remote job
Worldwide
Flexible hours
...pharmaceutical regulatory submissions and product approvals Proven track record of effective collaboration with regulatory agencies, including FDA, EMA, and PMDA; experience with PMDA is a minimal requirement Demonstrated leadership success in management of regulatory activities...
Suggested
Remote job
Worldwide
Flexible hours
...have been part of the Quality, Compliance or Regulatory department)
~ Extensive working knowledge and understanding of ICH GCP, US FDA, and other relevant regulations; US required, EU desired
~ Direct auditing experience (ability to travel approx. 20%)
~ Ability to...
Suggested
Full time
Contract work
...Affairs product files and ensure compliance with regulatory requirements.
Ensure compliance with Thermo Fisher Scientific, U.S. FDA, EU MDR/IVDR, Korea MFDS, China NMPA and other international medical requirements.
Participate on audit and field action...
Suggested
...collection, including donor set-up, donor monitoring and donor disconnect.
•In compliance with SOPs and Food & Drug Administration (FDA) guidelines, performs venipuncture on donors to begin pheresis process.
•Evaluates vein performance of the donor to identify...
Suggested
Holiday work
Full time
Temporary work
Local area
...and other company programs and procedures, and in accordance with government codes and regulations.
~ Demonstrated adherence to FDA regulations, Good Manufacturing Practices(GMPs), OSHA standards, HACCP, and sanitary processes/procedures.
~ Responsible for keeping...
Suggested
Hourly pay
Immediate start
Flexible hours
Shift work
..., medical device industry
preferred
•Excellent written, verbal, and interpersonal communication skills required
•Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing
processes desired
•Proficiency in Word, Excel, PowerPoint...
Suggested
Holiday work
Temporary work
Local area
...and subsequent regulatory filings. Interact and negotiate with regulatory agencies on defined matters as needed. Apply knowledge of FDA and Medical Device Regulations (including 21 CFR Parts 11, 50, 54, 56, 803, 806, 807, 812, 814 and other FDA guidance), as well as EU...
Relief
Worldwide
...and verbally
Must be comfortable and effective acting as a catalyst for change
Nice-To-Haves:
~ Experience with ISO13485 and FDA CFR a plus
Benefits And Perks:
Working with a team of 'rockstars' who bring out the best in everyone
Open, transparent culture...
...requirements and standards for medical devices, ensuring materials and testing protocols comply with applicable regulations (e.g., ISO 10993, FDA guidance documents)
•Travel ~10%. May be required to attend domestic and international trade shows, seminars and conferences...
...loading of tractor trailers throughout shift
* Administer and adhere to all governmental and Company regulations / policies (USDA, FDA, OSHA, FMLA, etc)
* Maintain the power equipment in proper running order. Coordinating repairs with maintenance department
* Perform...
Seasonal work
Local area
Shift work
Night shift
...Working knowledge of IVD regulations, such as IVDR and IVD quality strategy is a plus
GLP experience is a plus
Understanding of FDA + Global regulations and Guidance for GLP/ GCLP, and how to apply them
Must have experience advising business in a compliance...
