Average salary: $185,000 /yearly
More stats ...Notes: Firm is seeking an associate with 5-10 years of experience in FDA regulation. Preferred experience includes counseling companies with FDA-regulated products, reviewing contracts, and supporting corporate deals involving such regulated companies, including risk assessment...
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Worldwide
Notes: Firm is seeking an associate with 4-6 years of experience in drug and medical device regulatory compliance issues, specifically current good manufacturing practice (CGMP) matters. Prior industry experience in pharmaceutical manufacturing or a scientific background...
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...Job Description
Job Description Program Manager, Food and Drug Administration (FDA) Consulting
Prometheus Federal Services (PFS), a trusted partner to federal health and social services agencies, has an opening for Program Manager with Food and Drug Administration...
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Contract work
For contractors
Local area
Remote job
Flexible hours
Shift work
...https://www.kinneyrecruiting.com/jobs/?jid=515240
Description
Kinney Recruiting is working with an Am law firm to find a senior FDA regulatory associate with 5+ years of experience to join their firmwide practice. The idea attorney will have experience providing...
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...research networks, Compass Oncology participates in leading-edge clinical trials through US Oncology research, which has helped develop 89 FDA approved cancer therapies. We serve the Portland and Vancouver communities with clinical offices located throughout the metro area....
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Hourly pay
Permanent employment
Full time
Local area
Flexible hours
...groundbreaking, full-body Electro-Muscle Stimulation (EMS) workout that is designed to enhance your fitness at every stage of life. Our FDA-cleared EMS technology works with your body rather than against it, delivering personalized and efficient strength, power, cardio,...
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Permanent employment
Full time
Remote job
Flexible hours
...Visual Studio).
Experience writing and debugging test scripts – Ruby preferred, other languages acceptable.
Experience with ISO, FDA, or other regulated product development environments strongly desired.
Skills and Abilities:
Must be able to multi-task effectively...
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Holiday work
Permanent employment
...Seven or more years of product development experience, with at least five years designing electro-mechanical devices or a similar type FDA regulated medical device strongly preferred.
In-depth knowledge of mechanical tolerance analysis and Designed Experiment Techniques...
Suggested
Holiday work
Permanent employment
Contract work
...activities accurately and in a timely manner;
Responsible for the safekeeping of all medication stock and the records required by the DEA, FDA, and ADP;
Dedicates a minimum of 90% of regularly scheduled work hours to activities directly related to the administration of...
Suggested
Hourly pay
Permanent employment
Full time
Local area
Relocation bonus
Shift work
Saturday
Early shift
...simulation, algorithm development, and tool development
Extensive experience in product development from conception to release
ISO, FDA or other regulated industry training and experience
Skills and Abilities:
Track record of ownership in leading-edge product...
Suggested
Holiday work
Permanent employment
...requirements of the company's quality system.
Knowledge and Experience:
Requires 3-5 years relevant industry experience, preferably in an FDA or other regulated industry.
BS in an engineering discipline (ME, EE, BIO E or similar).
Knowledge of mechanical design and...
Suggested
Holiday work
Permanent employment
...activities accurately and in a timely manner;
Responsible for the safekeeping of all medication stock and the records required by the DEA, FDA, and ADP;
Dedicates a minimum of 90% of regularly scheduled work hours to activities directly related to the administration of...
Suggested
Hourly pay
Permanent employment
Full time
Local area
Trial period
Relocation bonus
Sunday
Day shift
Early shift
...compliance with all Federal and State Laws and Regulations, including the submission of corrective action plans to said agencies i.e. FDA, DEA, and State ADP;
Responsible for the security of medications, medical records, employee records, and any other documentation...
Suggested
Permanent employment
Full time
Local area
Early shift
Monday to Friday
...Manage and coordinate revisions of our quality management system (QMS) documentation for product security, adhering to FDA and legal requirements.
Develop project timelines, scope documents, stakeholder, and communication management plans.
Utilize...
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Full time
Part time
Local area
Remote job
...COVID-19. Toward that goal, the National Partnership requires all employees to be fully vaccinated and completely up to date via an FDA authorized and/or approved COVID-19 vaccination. Fully Vaccinated is defined by the CDC as being 2 weeks after the final dose in a primary...
Suggested
Holiday work
Full time
Local area
...vaccination against COVID-19 to work in our restaurants must as a condition of employment provide proof of full vaccination with an FDA authorized and/or approved COVID-19 upon hire, subject to a reasonable accommodation being granted. For roles in all other markets, full...
Holiday work
Casual work
Local area
Flexible hours
Shift work
...residents, fellows, and other members of hospital. Execute tasks required to maintain accreditation with JCAHO, CAP, DCRA, AABB, and FDA
Skills:
Training from qualified Medical Technology Program
Registration ASCP or Equivalent Board of Registry
Minimum 2 years...
...appropriate standards/regulations
Coordinate, prepare and review documentation for international and domestic submissions for to FDA, Health Canada and other international regulatory agencies.
Strategically achieve and maintain a balance between regulatory...
Local area
...be considered.
COVID-19 Policy:
Regardless of work location, all staff of The Raben Group must show proof of having received an FDA authorized COVID-19 vaccination or provide a vaccination waiver. New employees must provide proof of full COVID-19 vaccination or...
Internship
Shift work
...knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. This position may direct the work of junior staff, train personnel and direct the work of a Clinical Research Assistant...
Work experience placement
Internship
Night shift
...contractor shall possess ten (10) years of industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
The contractor shall possess five (5) years of project management experience in cost, schedule, performance, risk analysis...
Permanent employment
Contract work
For contractors
Remote job
...aptitude for detail. Knowledge of research guidelines and regulatory requirements established by such federal and state agencies as the FDA, National Institutes of Health (NIH), Benaroya Research Institute (BRI) at Virginia Mason and database collection. CPR certification...
Permanent employment
...Coordinate and work closely with logistical support agencies to identify logistical needs and develop plans when product reaches FDA approval.
The contractor shall support the responses to requests for information from the White House, recipient jurisdiction, organization...
Contract work
For contractors
Immediate start
...from the existing location of the tattoo.
Equipment will have various wavelength capabilities and various pulse durations and is FDA approved. All laser equipment, procedures, training, certifications, and reporting requirements will be conducted in accordance with...
Flexible hours
...Direttiva ATEX, Testo unico per la sicurezza Dlgs. 81/08)
Conoscenza delle norme di riferimento e legislazione in ambito Qualit (EU/FDA cGMP, Linee Guida, Normative)
Conoscenza delle modalit di conduzione collaudo apparecchiature (FAT/SAT) e gestione commissioning...
...Education
~ Master's degree in Healthcare field or life sciences required
Experience
~ Excellent working knowledge of FDA, ICH, GCP and other regulatory functions required
~10+ years' experience in phase I-IV clinical trials and knowledge of medical field...
Local area
...knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations. The Lead Clinical Research Coordinator may directly supervise a limited number of Clinical Research Coordinators or...
Work experience placement
Night shift
...hours. The CRC2 is instructed and required to maintain regular contact with each patient in their respective trials, because it is an FDA requirement to report adverse events in a timely manner, no matter the severity. As such, clinical trial patients develop close...
Full time
Part time
Work experience placement
We are seeking a dedicated and innovative Mid-Level BI Developer to join the NIRA project team, a key initiative in the FDA's digital transformation journey. This role is crucial for developing and implementing information dashboards and process automation solutions that...
Immediate start
...agency organization, guidelines, and practices and ability to negotiate with these groups
+ Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
+ Understanding of new drug commercialization and...
Remote job
Worldwide
Flexible hours