Experience
1 - 3 yrs
Job Location
Sonipat, India
Vacancy
1
Designation
Executive Regulatory Affairs
Job Type
ONSITE
Job Description
- Prepare documentation for FDA medical device approval and respond to inquiries.
- Ensure compliance with MDD, ISO 13485:2016, ISO 14971:2012, and Medical device Rules 2017.
- Develop and implement test strategies, plans, and cases for validation and verification.
- Lead roles in one or more FDA submissions for medical device approval.
- Manage projects and analyze/interpret test data.
- Collaborate with cross-functional teams to ensure regulatory compliance.
Job Requirements
- Minimum B.Tech in Mechanical, Biomedical, B.Pharma, B.Tech Bio Medical Science, or a science discipline.
- At least 2 years of experience in implementing test strategies, plans, and cases for validation and verification in the FDA-compliant medical device industry.
- Demonstrated success in a start-up or entrepreneurial environment.
- Thorough knowledge of FDA Quality System requirements, ISO 13485:2012, ISO 14971, MDD, GMP, and applicable Quality System Standards.
- Experience in verifying and validating products incorporating scalable data acquisition, processing, management, and reporting functionalities.
- Experience with QMS implementation that complies with MDD, ISO 13485, and ISO 14971 standards.
- Proficiency in analyzing and interpreting test data.
Additional Info
If interested, please forward your updated resume to and contact us directly at 8427933492. You can also refer your friends and colleagues.
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