Search Results: 288 vacancies
...NPI), and product development life cycle activities
Experience working with complex instrumentation and hardware
Experience in FDA-regulated environment and document control management
Salary and Benefits:
The annual base salary compensation for this role, if...
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Temporary work
Part time
Flexible hours
...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...
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Worldwide
...years related experience in the area of quality engineering for medical device manufacturer
~ Working knowledge and application of FDA QSRs and ISO 13485, MDD requirements. Audit experience a plus.
~ BS degree.
~ Excellent communication, interpersonal and organizational...
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Contract work
Work visa
...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...
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...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...
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Relief
Worldwide
...solving
Excellent oral and written communications, including good presentation and technical writing
Functional familiarity with the FDA Submission process, ISO Requirements and QSR requirements are preferred, but not required.
Requires the ability to travel...
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Full time
Temporary work
Relief
Remote job
...practical experience (Advanced degree preferred)
Minimum of 6 years in clinical research project management
Strong experience with FDA regulations for clinical trials and GCP
Ability to work effectively in teams and independently
Ability to manage multiple...
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...process outputs, and maintaining validated lines
Support overarching company goals, including but not limited to compliance with FDA regulations, ISO 13485, and any other applicable standards
Actively foster a positive working environment through clear communication...
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For contractors
...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/...
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Full time
Contract work
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For contractors
Work experience placement
Immediate start
Remote job
Worldwide
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...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...
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Full time
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Local area
...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...
Suggested
...regulations/guidance, can interpret guidance documents and make technical recommendations. (QbD, ICH Validation of analytical procedures, FDA regulations)
~ Excellent oral and written communication skills to effectively communicate with internal/external stakeholders, and...
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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...
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Full time
Contract work
...renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
* Audit operations, including...
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Full time
Work from home
...party vendors and closely collaborate with cross-functional internal and external stakeholders to ensure adherence to GCPs, SOPs, and FDA/ICH guidelines and delivery of high quality data within the defined timelines and budget.
The role is based in San Carlos, CA....
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...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...
...Execution focused, driven team: Join a team with an incredible record - we are the smallest, fastest company in history to receive FDA hematology clearance. We are also the largest Remote Patient Monitoring company in the US, with a fast-growing SaaS Revenue Cycle Management...
Private practice
Remote job
...glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing syndrome).
Today, our team and...
Full time
Contract work
Shift work
...teams to implement GxP processes.
Enhance quality culture at Palantir.
Support life sciences sales cycle, support customer and FDA audits regarding Palantir's Quality Management System, and complete assessment questionnaires for Life Sciences clients.
Support Implementation...
Work experience placement
Remote job
Relocation bonus
