Search Results: 283 vacancies
...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
Permanent employment
Relief
Worldwide
...global label competitive intelligence, and make recommendations for actions
· Plan, support and advise in liaison and negotiation with FDA and other agencies as needed for labelling content
· Ensure and maintain tracking and archiving of approved labels
· Develop...
Suggested
Permanent employment
Local area
...schedule.
The Quality Specialist I will be responsible for ensuring Steri-Tek is compliant with all applicable regulatory standards (FDA and DEA) including ISO 13485 and 11137, and that all Quality Systems Procedures are followed, respond to customer inquiries relating...
Suggested
Hourly pay
Permanent employment
Full time
Monday to Friday
...training to execute their roles.
Assure that activities are following compliance in the respective areas that are applicable from FDA GMP/GLP, ISO 13485/8, CMDR, CMDCAS, Medical Device Directive, Japan (ordinance 210, GMP, GPMI, Pharmaceutical Affairs Law) and other...
Suggested
Permanent employment
...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 treatment...
Suggested
Minimum wage
Permanent employment
Relief
Local area
...regulatory activities required for product market entry.
What You'll Work On
Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
Creates, reviews and approves...
Suggested
For contractors
Work experience placement
Worldwide
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...
Suggested
Full time
Immediate start
Remote job
...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
...tracking, distribution of executive and department communications, expense and TEO coordination, timekeeping support, and acting as an FDA on-behalf-of as well as serving as department point of contact.
Useful skills/knowledge for this role may include the following:...
Suggested
Full time
Remote job
Shift work
...procedures
Conducting tests and documenting test reports
Responsible for processing ECOs and other documentation in compliance with FDA guidelines and ISO requirements
Interface with other departments such as Marketing, Manufacturing, Regulatory and Quality...
Suggested
Permanent employment
Full time
Temporary work
Relief
...of the problem.
~ Supplier Development and Management experience.
~ Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO 13485, ISO 14971, and all other international regulatory requirements with which client complies...
Suggested
...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...
Suggested
Full time
Local area
Remote job
Shift work
...or High School diploma with 2-4 years related experience.
Experience in a pharmaceutical, medical device, bioscience, or other FDA-regulated environment required.
Must be familiar with cGMP and FDA requirements.
Knowledge of aseptic techniques helpful....
Suggested
Contract work
Local area
Immediate start
...•Knows, fully understands the purpose of operational practices, health & safety regulations, OSHA requirements, and ISO9000/ISO13485/FDA 21CFR820 quality procedures, and works accordingly.
•Ensures that health and safety procedures are adhered to and that considerations...
Suggested
Day shift
Monday to Friday
...required
Provide input, feedback and data for Quality report outs, Management Review, etc.
Support internal and external audits (FDA, ISO, MDSAP etc.)
Minimum Requirements/Qualifications:
Minimum BS/BA in scientific discipline (preferably chemistry or chemical...
Suggested
Local area
Shift work
...demonstrated experience creating technical documentation
Knowledge of applicable standards and laws regarding medical technology (e.g. FDA requirements, European MDR, ISO 60601-1, etc.) and ability to deliver work output in compliance to those standards
Must be able to...
Local area
...other operators, employees, other departments and Production Supervisor. Produces all Products in food safe manner in compliance with FDA, USDA, and AFNA. Partners with other functional areas to provide immediate solutions to safety, quality and cost issues. Holds...
Local area
Immediate start
Weekend work
...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...
Contract work
Part time
Work experience placement
Immediate start
Remote job
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...
Local area
Worldwide
...Experience: Minimum of 3 years experienceSkills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)
Duties: Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers,...