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Regulatory Affairs Specialist
Cyient
posted 9hr 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 guidances, 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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What people at Cyient are saying
Rating based on 1 Regulatory Affairs Specialist
review
Anonymous · Legal & Regulatory
in Hyderabad / Secunderabad
Likes
Smooth and balanced
- Skill development - Good
+4 more
Dislikes
Employee benefits are less comparatively
Regulatory Affairs Specialist salary at Cyient
reported by
7
employees
with 2-8
years exp.
₹5
L/yr - ₹8.5
L/yr
17%
less
than the average Regulatory Affairs Specialist Salary in India
View more details
What Cyient employees are saying about work life
based on 4.4k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Cyient Benefits
View more benefits
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