Search Results: 32 vacancies
...production to maintain medicine inventory.
Explore patient information leaflets by amalgamating online sources, journals, books, PubMed, FDA, and studies.
Oversee the drug database and generate comprehensive drug profiles.
Scrutinize the drug database to ensure it is...
...materials and manufacturing problems
Maintain quality standard as per FSSAI, FEMA (Flavor and Extract Manufacturers Association) & FDA (FOOD & Drug Administration) guidelines & regulations
New Product Development Projects - Assist Product Development Managers by managing...
...detail, accuracy and organizational skills.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what...
...AIX is a plus
Strong Troubleshooting skills and must have very good conceptual knowledge of Oracle Database
Exposure to SOX and FDA audit and compliance procedures
Exposure to international / medical companies
About Stryker
Stryker is one of the world's leading...
...experience in complaint handling or customer quality.
~ Understanding of Post Market Surveillance requirement of Medical Devices under FDA & EU MDR regulations
~ Understanding on Medical Device Risk Management
~ Hands-on Experience on Complaint handling and Product...
...groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...
...minimum of 3.5-6 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)).- Experience in managing and leading testing related activities. - Experience in creating test scenarios and testing protocols...
...planning, cost estimations, DevOps, and Security
~ Experience with documented software development processes or familiarity with US FDA and ISO standards like IEC 62304, IEC 60601, and 21CRF 820 is a good understanding of HL7 and DICOM protocols is a plus
About Stryker...
...assigned task with high quality
~ Experience handling industry standard public databases/ data sources like Clinicaltrials.gov, Pubmed, FDA website, EMA website; and/or paid databases like Citeline, Evaluate Pharma, PharmaTell, etc.
~ Excellent written and verbal...
..., designing, and documenting software architecture
Experience with documented software development processes or familiarity with US FDA and ISO standards like IEC 62304, IEC 60601, and 21CRF 820 is a plus
Good understanding of HL7 and DICOM protocols is a plus
About...
...software, hardware)
Product development experience in a regulated environment (Medical devices, Aerospace etc.). Understanding of US FDA quality regulations 21CFR part 820, ISO 13485 standards is a plus.
Good to have experience of Software Engineering critical experience...
...Software testing techniques including manual and automated testing
Preferred Qualifications (Strongly desired):
. Experience in an FDA or other regulated industry highly preferred.
. Expert knowledge with networking including switching, routing, sniffing, ports and...
...system (ODS), etc.)
Ability to work with multiple data sources and large datasets (millions of records)
Previous interaction with FDA submission is desired; experience in design and/or analysis of surveys a plus
Advanced applied statistical skills: Fisher's exact test...
...Technical Knowledge:
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-Experience in Quality Systems and Design Assurance
-Working knowledge of ISO 13485 and FDA 21 CFR Regulations and BS EN ISO 14971
-Software: Knowledge and experience of Word, Excel, PowerPoint and Minitab
-Knowledge of...
...inform, influence, convince, and persuade.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what...
...in support of production and regulatory filings.
Experience
2 - 7 years experience in a cGMP laboratory
Familiar with cGMP and FDA requirements
~ Bachelor s Degree in Chemistry or closely related degree with experience.
Perform analytical testing and...
...Years
MustHave:
Experience in CSV (Computer System Validation)
Understanding of the regulatory guidelines for IT systems primarily FDA EMA MHRA and PMDA
JD:
1. Exposure to pharmacovigilance domain and drug safety applications Argus or ArisG/J
strong preference...
...measures to maintain a safe working environment
Adhere to regulatory guidelines, such as those set by the Food and Drug Administration (FDA) and other governing bodies
Qualifications:
Education and Certification: A high school diploma or equivalent is typically...
...experience in complaint handling or customer quality.
~ Understanding of Post Market Surveillance requirement of Medical Devices under FDA & EU MDR regulations
~ Understanding on Medical Device Risk Management
~ Hands-on Experience on Complaint handling and Product...
...etc. will be an advantage
Should be aware of free to use online resources like – WHO, USFDA, CDC, CMS, PubMed, UNSD, Eurostats, NORD, FDA warning letters, etc.
Ability to understand the link between client needs, data and its application
Excellent interpersonal, oral...
