Compliance Specialist

We currently looking for Medical Device Affairs and Compliance Specialist for one of our entity Faith Innovations. please find the following Job Description. 1. Designation:- Compliance Specialist ( Male only ) Salary:- 25K -35K/PM Location:- Delhi Company:- Faith Innovations No. of positions 01 Educational Qualification: B. Tech (Electrical & Mechanical engineering) Experience: Mandatory: 2-3 yr in the medical devices QA/RA Drive completion of compliance requirements whenever assigned by the Compliance team and/ or Function head i.e., to update and review records and documents for completeness and compliance as per MDR and ISO requirements Ability to understand the classification of medical devices as per Medical Device Rules 2017 and assist in the preparation of technical files and medical device master files for regulatory submission. To understand and have knowledge on the implementation of the Risk Management File, Plan and Procedures as per ISO 14971. Reviewing and handling of the incidents received from the Notified body or Competent Authority and updating and reviewing SOPs for accuracy and completeness as applicable under medical device regulations or under CE class journey Participates and provide full support in all regulatory audits. Knowledge and experience of CDSCO Should have knowledge of quality control is a plus.