Company Description
MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
Job Description: Jr Regulatory Affairs Executive
- Preparation, Review and submission of Technical documents (CTD/ACTD) for Devices of Regulatory and Non Regulatory Markets.
- Submission build activities, creating inter-document links, performing a quality checks and validating compiled submissions, and finalizing submission by the required dispatch date.
- Coordination with the team for timely submissions.
- Reviewing manufacturing documents like MFC, BMR, MDR/IVDR/IVD process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol and PDR.
- Preparation and review of the response to the Agency's queries and submission within the stipulated time given by health authorities.
- To develop and deliver complete regulatory submissions within agreed timeframes. Providing regulatory support to project teams for assigned projects.
Requirements
A minimum of 1 - 2 years of experience within Regulatory & Medical Devices/IVDR/MDR skills and CRO or Medical Devices or Biopharma industry side.