| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
| Oil & Gas Jobs |
| Banking Jobs |
| Construction Jobs |
| Top Management Jobs |
| IT - Software Jobs |
| Medical Healthcare Jobs |
| Purchase / Logistics Jobs |
| Sales |
| Ajax Jobs |
| Designing Jobs |
| ASP .NET Jobs |
| Java Jobs |
| MySQL Jobs |
| Sap hr Jobs |
| Software Testing Jobs |
| Html Jobs |
| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
02. Quality Assurance and Regulatory Manager - Position OPENDesired qualificationsBachelor s Degree in Engineering , Science , or health - related fieldMinimum RequirementsWorking knowledge of CE , FDA and other regulatory authoritiesFDA Regulatory submission experience (510ks , PMAs , IDEs)Quality Systems development , implementation , and training experienceExperience with ISO 13485 , FDA , MDD (EU Medical Device Directive)compliance requirements.Experience with FDA remediation , Warning Letters , 483 Observations , and Recalls a plusMust be able to work independently and have ability to work with cross - functional teamsResponsibilitiesDevelop and maintain submissions to regulatory agencies required to allow Leben products to be sold in all regions and markets. (FDA , CE)Develop and maintain the Leben QMS and supporting procedures to adhere for ISO 13485 , as well as FDA , European (CE Mark)requirementsManage QA and QC team and ensuring their adherence to producing a quality product.Develop product documentation for regulatory submissions.Desirable SkillsSound understanding of Quality Assurance methods.Proficient in the Microsoft family of products.Familiarity with defect tracking software packages.,
Keyskills :
development methodstudy well compliance functional health eu des manageteam producer