Regulatory Affairs Specialist @ Sutherland

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Regulatory Affairs Specialist

Sutherland
8 - 13 years
Pune
3 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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Please, check the file size and type.

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Sutherland

Sutherland Established in 1986, Sutherland Global Services is a global provider of business process and technology management services. Sutherland offers an integrated portfolio of analytics-driven back-office and customer facing solutions that support the entire customer lifecycle. One of the l...

Regulatory Affairs Specialist @ Sutherland

Home > Quality Assurance - Other