Biocon Biologics Released Job Openings On 19/02/2022.Biocon Biologics is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.
Vacancy Details:
Biocon Biologics Recruiting Any Graduates with 10-16 Years of Experience for Manager Regulatory Affairs Medical Devices Position.Complete Details for the Manager Regulatory Affairs Medical Devices as follows.
Important Details :
- Location : Bengaluru
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 19/02/2022
- 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
Related Job : WhatsApp / Teams Interview At Omega Healthcare From 21st – 22nd Feb 2022Â
Job Description/Skills Required
- Planning and execution of device (Combination product) regulatory submissions and all other regulatory related activities, globally
- Authoring, review and submission of device related sections of different combination products
- Preparing the response and submission for any agency queries on device activities
- Device related post approval variation submissions of different combination products
- ISO13485 / CE certification audit compliance of regulatory activities and post audit management
- Responsible for US FDAs 510K submission activities and EUs MDR(2017/745) transition, from MDD(93/42/EEC)
- Responsible for activities associated to Devices, in the dossier preparation for biosimilar product under BLA/IND/IMPD/MAA and perform appropriate review, as required
- Coordinating with partners, customers and authorities for dossier finalization, query response and submission, as required
- Responsible for device regulatory related SOPs revisions/ Update as required
- Responsible for device regulatory guidelines revision communication and ensure those revisions are implemented
- Regulatory activities include but are not limited to guiding the team for preparation of medical device CE marking technical file, registration dossiers for emerging markets, updating drug registration dossiers with device information as appropriate, deficiency response, post approval changes etc.
- Review and assessment of QMS elements related to combination products
- Supporting Activities for ensuring GMP compliance
- Train the team members and cross functional teams on combination product requirements
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