Regulatory Affairs Specialist @ Sutherland

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Regulatory Affairs Specialist

Sutherland
8 - 13 years
Pune
10 months ago
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Job Description

Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline;

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.)

Job Classification

Industry: IT Services & Consulting
Functional Area / Department: Quality Assurance
Role Category: Quality Assurance - Other
Role: Quality Assurance - Other
Employement Type: Full time

Contact Details:

Company: Sutherland
Location(s): Pune

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Keyskills: USFDA Iso Standards Regulatory Affairs QMS Quality Management Medical Device Regulations

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Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

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 @ Sutherland

Home > Quality Assurance - Other