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Regulatory Affairs Specialist
Cyient
posted 6d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
• 10+ years of professional experience in medical device regulatory affairs EU MDR, US FDA 510(k) and closely working R&D, Quality organizations.
• Strong proven experience creating Technical Documentation and 510(k) preparation and receiving submission approval (EU, Canada, US, etc.).
• Expertise in interpreting and implementing various medical device standards and guidance's, such as IEC 60601-1, ISO 14971-1, IEC 62366-1, ISO10993-1, and MEDDEV 2.7/4.
• Experience with systems for quality management, product development, and follow-up of procedures is an advantage.
• Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.)
Personality Characteristics
• Be able to handle ad-hoc changes in priority/planning and independently.
• Be able to think from customer expectation perspective
• Be able to work in different teams simultaneously
• Communicative & disciplined team worker
Employment Type: Full Time, Permanent
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People are getting interviews at Cyient through
People are getting interviews through
(based on 189 Cyient interviews)
Job Portal
Walkin
Campus Placement
Company Website
Referral
31%
13%
12%
12%
11%
21% candidates got the interview through other sources.
High
Confidence
?
High Confidence means the data is based on a large number of responses received from the candidates.
What people at Cyient are saying
Rating based on 1 Regulatory Affairs Specialist
review
Anonymous · Corporate Affairs
in Hyderabad/Secunderabad
Likes
Smooth and balanced
Dislikes
Employee benefits are less comparatively
Read 1 reviewRegulatory Affairs Specialist salary at Cyient
reported by
7
employees
with 2-8
years exp.
₹5
L/yr - ₹8.5
L/yr
14%
less
than the average Regulatory Affairs Specialist Salary in India
View more details
What Cyient employees are saying about work life
based on 4.2k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Cyient Benefits
View more benefits
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