Search Results: 313 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...
Suggested
Temporary work
Part time
Flexible hours
...understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world's largest crowdsourced platform for genetic...
Suggested
Local area
3 days per week
...regulations
Must be able to travel internationally up to 10%
It would be a plus if you also possess previous experience in:
FDA / GMP 21CFR820
ISO 13485
Certified Lead Auditor
Reagent/Assay and other Material Consumable experience
Cepheid, a...
Suggested
Full time
Part time
Work experience placement
Immediate start
Remote job
Flexible hours
3 days per week
...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
...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 a wet and cold environment....
Suggested
Hourly pay
Holiday work
Traineeship
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world's largest crowdsourced platform for genetic...
Suggested
Local area
3 days per week
...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 a flexible schedule including...
Suggested
Holiday work
Full time
Part time
Flexible hours
Shift work
Night shift
Sunday
Saturday
...Science, or related scientific discipline such as Biology, Chemistry, or Engineering
2 to 5 years in an EH&S role, preferably in the FDA regulated/medical device industry. Professional certification preferred but not required.
Innovation: Sound working knowledge of...
Suggested
Permanent employment
Temporary work
Local area
...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
...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
...related discipline or equivalent experience in the medical device industry.
Experience & Skills:
~ Experience and knowledge of FDA’s Quality System Regulations, ISO 13485, Medical Device Regulations (2017/745) and ISO 14971 Risk Management. Experience with Class...
Suggested
Full time
...regulations
Must be able to travel internationally up to 10%
It would be a plus if you also possess previous experience in:
FDA / GMP 21CFR820
ISO 13485
Certified Lead Auditor
Reagent/Assay and other Material Consumable experience
Cepheid, a...
Suggested
Part time
Work experience placement
Immediate start
Remote job
Flexible hours
3 days per week
...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...
Suggested
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...
Suggested
Full time
Temporary work
Relief
Remote job
...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
...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
...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...
Contract work
For contractors
...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...
...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...
Hourly pay
Holiday work
Flexible hours
Night shift
...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....
Local area
Remote job
