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Quality Assurance - Regulatory Affairs

iTech US Inc
Miami, Florida, United States
February 15, 2018

iTech US a leading global workforce management provides end-to-end solutions for customized Software Development Solutions and staffing solutions provider to Fortune 1000 firms .

Globally who trust us to design, execute and manage sophisticated workforce management solutions, large scale staffing engagements and strategic Business Process and consulting engagements.

We have Quality Assurance - Regulatory Affairs Job in Miami, FL

If you are seeking to apply please do share your updated resume, contact detail and best time to reach you.

Job Title: Quality Assurance / Regulatory Affairs

Location: Miami, FL

Duration: 6 Months Contract to Hire

Job ID: 6722

Note: Required Local Resident Applicant - Required to attend In Person Interview.

Primary Responsibilities

1. Lead and execute complex regulatory projects - implementation of new regulatory requirements, etc.

2. Assist in development of regulatory strategy

3. Investigate and evaluate regulatory history / background of class

4. Review change orders and assess regulatory impact of product changes on international regulatory strategy and submissions

5. Support post-market regulatory compliance activities

6. Provide regulatory review of labeling, design changes, and specification changes

7. Work with RA teams and develop international strategies for product submissions

8. Other duties as assigned

Required Skills & Abilities

1. Bachelor's degree in Engineering or related field

2. 4 years of relevant work experience in a similar role in Medical Device domain

3. Knowledge of regulation of Medical Devices for US and Europe

4. Knowledge of upcoming regulatory changes

5. Knowledge of FDA requirements and guidelines

6. Knowledge of 21CFR820 regulatory requirements

Thanks & Regards