Regulatory Affairs Specialist @ Top Rated

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Regulatory Affairs Specialist

Top Rated
7 - 8 years
Pune
1 month ago
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Job Description

Educational Qualification:

Degree in Mechanical Engineering, Electrical Engineering, Applied Sciences, or a related discipline.

Professional Experience:

10+ years of experience in Medical Device Regulatory Affairs with expertise in EU MDR and US FDA 510(k).
Strong collaboration with R&D and Quality Assurance teams.
Proven experience in creating Technical Documentation and preparing 510(k) submissions, including successful approvals in the EU, Canada, and the US.

Technical Expertise:

In-depth knowledge of medical device standards and guidance documents, including:

IEC 60601-1
ISO 14971
IEC 62366-1
ISO 10993-1
MEDDEV 2.7/1 Rev. 4

Quality Systems Knowledge:

Proficient in Medical Device Quality Management Systems, including:

ISO 13485
MDSAP
EU MDR
Risk Management processes

Experience with systems supporting quality management, product development, and procedural compliance.

Job Classification

Industry: Medical Devices & Equipment
Functional Area / Department: Legal & Regulatory
Role Category: Legal & Regulatory - Other
Role: Legal & Regulatory - Other
Employement Type: Full time

Contact Details:

Company: Top Rated
Location(s): Pune

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Keyskills: USFDA Regulatory Affairs Eu Mdr Medical Devices

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₹ 14-18 Lacs P.A

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Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

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Regulatory Affairs Specialist @ Top Rated

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