Regulatory Affairs

7 days ago

Faridabad, India Polymed Full time

**Regulatory Affairs**:

- From 0 to 5 year(s) of experience
- ₹ Not Disclosed by Recruiter
- Faridabad ( Ballabhgarh)- or
- To coordinate with marketing for collecting, analyzing and making PMS, PSUR & PMCF report for various products
- Registration of all devices on Eudamed and uploading required documents on eudamed
- To search relevant literatures including adverse event on various scientific website e.g. PubMed, MAUDE following PICO process. Appraise, analyze and finalize the searched literature based on acceptance criteria
- Updating risk management based on analysis of total complaints, any new hazards observed during PMS. Verification of IFU as per residual risks and usability. Analysis of customer complaints and verification with risk analysis
- Writing comprehensible, user friendly, clear product information
- Ensuring that quality standards are met and submission meet strict deadlines
- Keeping up-to date with latest changes in regulatory legislation and guidelines
- Key Skills- Communication SkillsWritten CommunicationAnalyticalregulatory affairsComputer Skills- Presentation SkillsPressure HandlingOrganizing- Skills highlighted with ‘‘ are preferred keyskillsEducation
- UG:_B.Tech/B.E. in Bio-Chemistry/Bio-Technology,B.Pharma in Any Specialization
- PG:_M.Tech in Bio-Chemistry/Bio-Technology,M.Pharma in Any Specialization

**Company Profile**:
Polymed
- POLYMED was conceived and established by a group of making the benefit of modern healthcare available to the mankind at affordable price. POLYMED's main strength is its fully committed, well trained and technically competent personnel.- Company Info- X- Contact Company:_Polymed
- Address:_Plot No.104 105,,HSIIDC Industrial Area,Sector-59,, Ballabgarh, FARIDABAD, Haryana, India

**Salary**:
Not Disclosed by Recruiter

Industry:
Medical Devices & Equipment

Functional Area:
Legal & Regulatory

Role Category:
Corporate Affairs

Role:
Head - Regulatory Affairs

Employment Type:
Full Time, Permanent

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