Genpact Released Job Openings On 03-12-2021.Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and industry expertise to deliver disruptive business outcomes – an approach we call Lean DigitalSM…Eligibility Criteria / Educational Qualification, Official Notification, Apply Online Form Link & Other Relevant Details for Genpact Recruitment 2021 are provided below. Interested and eligible candidates can submit application along with resume.
Genpact Recruiting B.Pharma,M.Pharma,B.Sc,M.Sc,B.Tech Candidates with 04-09+ Years of Experience for Lead consultant Regulatory-affairs Position.Complete Details for the Lead consultant Regulatory-affairs as follows.
Important Details :
- Location :Mumbai
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application:03-12-2021
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- Experience in international medical device regulatory affairs for registrations all over the world, specific experience in Computerized tomography and Diagnostic Cardiology is preferable.
- Expert in preparing and handling 510 k submission for US. Experience in class II devices (Computerized tomography and Diagnostic Cardiology) is preferable
- Hands on experience in preparation and review of technical files.
- Hands on experience in preparing complete medical device dossier for registration into multiple markets
- Response to queries/Non-conformities raised by Ministry of health of various countries, Auditing organization/Notified bodies
- Well aware of CE requirements for regulatory compliance as per New MDR 2017/745 and ISO 13485:2016 , US regulations like 21 CFR 820, 807,801 and worldwide regulatory requirements
- Aware of labelling compliance as per different regulations
- Training to new joiners on medical device regulatory requirements.
- Maintaining updated record of work, assigning roles and responsibility within team, checking status of ongoing projects and communicating with stakeholders.
- Expertise in handling post approval changes in Medical device regulatory
- Must be aware of current scenario and latest new medical device rules and regulations.
- Ensured timeliness in Regulatory Applications
- Hands on experience on multiple electronic data management systems
- Active coordination and communication with various sites for arranging multiple documents
- Excellent Leading and communication skills