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Regulatory Affairs Executive
2 weeks ago
Opening with a client into medical Devices at Nayandahalli
Job Description Job Title:
Sr. Executive - Regulatory Affairs
Reporting To:
RA Manager.
Key responsibilities Duties:
- Experience in preparation of Device master file and other documents as per CDSCO MDR17 requirements and submission of documents in CDSCO portal.
- Experience in preparation and submission of documents for Manufacturing licenses, Import licenses and for the certificates for all Class of devices (Class A, B, C & D).
- Experience with preparing design & development documentation including risk management to align with the regulatory strategy especially for class IIb implantable & class III devices.
- Experience for compilation of technical file/complete design dossier as per CE (EU MDR), ISO 13485 and USFDA guidelines.
- Need to do documentation as per FDA & CE-MDR regulations and ISO standards. Perform audit compliances, analysing gaps, shortcomings as per FDA/ISO regulations.
- Understanding of cGMP regulations per 21 CFR and ISO Understanding of Risk Management per ISO 1947
- Knowledge on documentation on post market surveillance, PMCF, clinical evaluation and UDI.
- Exposure to EU Medical Device Regulation (EU MDR) 2017/24
- Knowledge on device registration process in different countries.
Qualification:
- Master's in Pharma with 2+ years of experience. OR Master's in Science with 2+ years of experience, BE with 2+ years of experience
- Technical writing,
- English communication and teamwork.
- Detail oriented, ability to read various standards and guidelines & define implementation details.
- Result oriented to develop and deliver components in a short span of time
Smita Dewoolkar
( Mobile & Whts app)
Job Types:
Full-time, Permanent
Salary:
Up to ₹500,000.00 per year
Schedule:
- Day shift
- Rotational shift
Experience:
- regulatory for class IIb implantable & class III device: 1 year (required)
- Regulatory reporting for medial device: 1 year (required)
- Compilation of Dossier fo EUMDR /
USFDA:
1 year (required)
Language:
- English (required)
License/Certification:
- Master's in Pharma OR Master's in Science ,BE (required)
Ability to Commute:
- Bangalore, Karnataka (required)
Work Location:
In person
Speak with the employer
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