Search Results: 318 vacancies
...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
...hour administration period.Click here for ZTLido's Important Safety Information and US Prescribing Information.
We have acquired two FDA approved non-opioid pain products, GLOPERBA and ELYXYBTM, for the treatment of gout in adults and oral solution for the acute...
Suggested
Minimum wage
Permanent employment
Contract work
Relief
Local area
3 days per week
...previous experience in:
Competent with the implementation of ISO 9001, with ISO 13485 preferred
Previous work experience in an FDA-regulated environment
Product transfer to a Contract Manufacturer (CM)
Cepheid, a Danaher operating company, offers a broad array...
Suggested
Contract work
Part time
Work experience placement
Immediate start
Remote job
Flexible hours
...development experience in Engineering or physical science.
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
Work experience placement
...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...
Suggested
Full time
Immediate start
Remote job
...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...
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Private practice
Remote job
...production preferred
•Previous laboratory or Quality Control experience
•Previous experience in the medical device industry or other FDA regulated industry
•Or, equivalent combination of education and experience
WORK ENVIRONMENT
The work environment...
Suggested
Second job
Flexible hours
...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...
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Full time
Local area
Remote job
Shift work
...analysis.
Lead engineering change process.
In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further...
Suggested
Local area
...others/teamwork, encourages participative decision-making
Excellent interpersonal & communications skills
Working knowledge of FDA regulations & other medical device regulatory compliance requirements; experience leading in a regulated environment preferred
Proficiency...
Suggested
...assigned
Other Responsibilities:
Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
Ensure that all internal policies are followed
Understand the job specific quality system procedures and processes...
Suggested
...0 pounds
* Physical dexterity; repetitive hand and arm motion single grasping, fine manipulation, pushing, pulling
* Exposure to FDA approved cleaning chemicals
* Exposure and work in varying temperatures: 90 degrees F
* Ability to work in wet and dry conditions...
Suggested
Holiday work
Full time
Flexible hours
Night shift
...manipulation, pushing and pulling.
Work requires the following motions: bending, twisting, squatting and reaching.
Exposure to FDA approved cleaning chemicals.
Exposure to temperatures: 90 degrees Fahrenheit.
Ability to work in wet and dry conditions.
Ability...
Suggested
Hourly pay
Holiday work
Flexible hours
Night shift
...required
~ Good computer skills are required
~ Working knowledge of MS word, Excel, Power point is a plus
~ Experience working in an FDA regulated environment is highly desired
~ Must be willing to work as part of a team and demonstrate good interpersonal skills...
Suggested
Work experience placement
Local area
...RESPONSIBILITIES:
Quality Management System (QMS) Leadership:
* Develop, implement, and maintain an effective QMS in compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
* Oversee the documentation and training programs related to the QMS,...
Suggested
Holiday work
Temporary work
Local area
Work visa
Relocation package
Flexible hours
...Experience:
Knowledge in medical imaging (Ultrasound, PET, SPECT, CT, MR, etc.) and developing software in the medical industry (FDA regulated)
Familiarity in ultrasound physics, signal and image processing, beamforming, transducer optimization, simulation, algorithm...
Full time
2 days per week
3 days per week
...public health and safety measures, EXOS requires that all successful applicants 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...
Local area
Worldwide
...interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
Awareness of relevant FDA, EU, and ICH regulatory guidelines as applicable to QC operations related to small molecules, biologics and vaccines, and expiry...
...Degree, preferably in engineering or other STEM-related field
At least 5 years of hands-on quality or regulatory experience in a U.S. FDA and ISO 13485 regulated environment
Experience with ISO 14971 and IEC 62304
Proven experience as quality representative on cross...
Remote job
Flexible hours
...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...
Remote job
For contractors
Flexible hours
