Junior Regulatory Affairs Executive

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 +001-2015, 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, Mechanical engineering with minimum of 2 years’ progressive Regulatory affairs experience in medical device & quality background.

Requirements:

Ensure that a company's products comply with the regulations of the regions
Keep up to date with national and international legislation, guidelines and customer practices
Collect, collate and evaluate scientific data from a range of sources
Monitor and set timelines for variations and renewal approvals
Work with specialist computer software and resources
Write clear, accessible product labels and patient information leaflets
Plan and develop product trials and interpret trial data
Advise scientists and manufacturers on regulatory requirements
Provide strategic advice to senior management throughout the development of a new product
Project manage teams of colleagues involved with the development of new products
undertake and manage regulatory inspections
Review company practices and provide advice on changes to systems
Liaise with, and make presentations to, regulatory authorities
Negotiate with regulatory authorities for marketing authorization
Take part in the development of marketing concepts and approve packaging and advertising before a product's release.
Knowledge about ISO +001 ,ISO 13485
Knowledge about MDR(Medical device regulations)
Job Types: Full-time, Regular / Permanent

Schedule: Day shift

Total work Experience: 2 to 3 Years

Language: English

Work Remotely: No

Salary: INR 15000 per month

Job Type: Full-time

Salary: Up to ₹15,000.00 per month

Ability to commute/relocate:

Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (Required)
Experience:

total work: 1 year (Preferred)
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