Regulatory Affairs

Job Title: Regulatory Affairs Junior ManagerLocation:At Ahmedabad Office , Near Thaltej CrossroadsDepartment:RAReports To:RA Head and Regulatory Department at HO /DirectorEmployment Type:Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday andSaturday Half DayPreferred Gender: M/FExperience : Minimum 2 yearsJob Summary:We are seeking a proactive and...

**Regulatory Affairs Expert Wanted**">About the Role: We are seeking a skilled Regulatory Affairs Executive to join our team.We are looking for a highly motivated individual with experience in regulated markets like USA/Europe/Australia. The ideal candidate will have a strong background in preparation of registration dossiers as per US Regulatory guidelines...

Regulatory Affairs LeaderThe role of the Regulatory Affairs Leader is to ensure that all regulatory activities are carried out in accordance with the highest standards.Key Responsibilities:Ensure all local registrations & compliances related to the registrations are being followed.Compliance with European Union (EU) regulatory requirements, including the...

Manage QMS & regulatory affairs strategies & submissions. Internal/External Audits & distributor audits,manage product registrations, import licenses & other approvals, Maintain PMS Data, Query resolving raised by DCGI, BIS, Customs or ADC port etc. **Department** All Departments **Open Positions** 1 **Skills Required**: Quality Assurance;Regulatory...

About the RoleAs a seasoned regulatory professional, we are seeking an experienced Senior Regulatory Affairs Specialist to lead our team in ensuring compliance with regulatory standards and requirements for medical devices. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions.">Main...

Salary: Competitive compensation package. Job Description: As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our products with regulatory requirements. Your responsibilities will include reviewing drug product dossiers, coordinating projects, and managing CMC regulatory requirements for various regions. You...

About Our ClientOur client is a global healthcare company committed to providing high-quality, affordable pharmaceuticals and healthcare solutions across emerging markets.Job Description- Management and coordination with Indian vendors of technical and legal requirements for getting the marketing authorization approval at the Health Authorities in LATAM...

Key Responsibilities:Provide technical support for proposal preparation and meetings with prospectsRepresent the company as an expert in regulatory affairs and pharmaceutical developmentPrepare or review CMC regulatory documents, including Module 3 and Quality Overall SummaryDevelop document writing strategies and define positions for variation foldersAssess...

Senior Regulatory Compliance SpecialistWe are seeking a highly skilled and experienced professional to lead the preparation, submission, and management of FDA 510(k) premarket notifications for medical devices.The ideal candidate will have a proven track record of authoring and managing regulatory submissions that ensure compliance with FDA regulations and...

jobid - 464066 jobfamily - Quality Management company - Siemens Healthcare Private Limited organization - Siemens Healthineers jobType - Full-time experienceLevel - Experienced Professional contractType - Permanent ce: 5-8 yrs Qualifications: You have successfully completed a course of studies in a technical or clinical field, preferably in...