Detail

Salary
negotiable
Location
MA, USA
Posted by: Sasha Sharma
17 Aug
339 Views
16 Oct EXPIRED

Regulatory Affairs Manager

MA, USA
Job Description

Location:Lexington,MA

Duration:12 Months+

Serve as the lead device regulatory affairs member of project development teams, primarily focused on (but not limited to) device products.

Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.

Specifically, supporting all device labeling activities, packaging and their regulatory content, IFU development and coordinating labeling deliverables with device QA. 



Job ID Reference
1252
Desired Skills & Experience

Develop regulatory submission strategies in agreement with defined product development objectives.

Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned device projects.

Prepare and submit device content for IND and NDA applications, or author 510K, and CE Mark regulatory filings.

Minimum of 5 years + experience in device development and registration activities, including personal management of an approved devices from initial development through to approval and market launch.

Prior project management experience a plus, with a demonstrated capability to lead and motivate staff is essential.

Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.

Company
   4 Ethel Rd, Suite 403B Edison, NJ 08817 United States
  7326627964
  www.irionline.com
Integrated Resources Inc. (IRI) is a professional staffing firm specializing in contract, consulting & full time positions in the area of Information Technology, Life Science and Allied Healthcare. Since its inception in 1996, IRI has continued to grow in size, opportunities, service and quality. Our expert team of highly trained counselors work hand in hand with every candidate and client forming a partnership of understanding and commitment.
Specialties
Staffing Recruiting in IT, Allied Healthcare ,Rehab Clinical, CRO Clinical Research Clinical Data Management
  Workplace
 MA, USA