Job details
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Pay
₹12,000 – ₹25,000 a month
Job type
Full-time
Shift and schedule
Day shift
Benefits & Perks
Provident Fund
Benefits
Pulled from the full job description
– Provident Fund
About Company: TEKNA manufacturing is a progressive fast growing medical device manufacturing company having their facilities in Florida, USA and Chennai, India. TEKNA products are US FDA cleared, and our facilities are ISO’s 9001-2015, 13485-2016, ASME and “U” stamp certified. We are multinational company having operation worldwide. For more information please visit https://hyperbaric-chamber.com/
We are in the process of hiring Regulatory Affairs
Job Title: Regulatory Affairs Executive
Key Responsibilities:
Qualifications:
Bachelor Degree in a related field such as Biomedical engineering with minimum of 2 years progressive Regulatory affairs experience in medical device.
Requirements:
1. Preparation of RMF, Technical file and annual/Periodic documents as per EU MDR and US FDA regulations.
2. Perform gap assessment against regulatory documents and standard documents.
3. Ensure that a company’s products comply with the regulations of the regions where they want to distribute them.
4. Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
5. Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the product.
6.
Knowledge on post market surveillance and Risk management activities.
Skills: Knowledge on CFR part 820, ISO 13485, ISO 14971, EU MDR, MEDDEV 2.7.1 rev 4
Total work Experience: 1 to 4 Years
Language: English
Work Remotely: No
Job Type: Full-time
Salary: ₹12,000.00 – ₹25,000.00 per month
Benefits:
– Provident Fund
Schedule:
– Day shift
Ability to commute/relocate:
– Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (Required)
Experience:
– total work: 1 year (Preferred)
Speak with the employer
+91 9551796796
▶️ Regulatory Affairs Executive
🖊️ Tekna Manufacturing
📍 Chennai
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