Sr. Regulatory Affairs Specialist – Rhode Island

Overview: Manage regulatory projects to ensure timely introduction of new products subject to medical device regulations in the U.S. and International. Summary of Position with General Responsibilities: •Prepare applications to the FDA for clinical testing and marketing of new and modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s) •Prepare application documentation for international marketing approvals (i.e. […]

Test Systems Engineer – Central MA – Medical Device Company

This position will offer the opportunity to develop highly specialized equipment for high throughput medical device testing. This new team member will have experience in development, integration and maintenance of test equipment for manufacturing tests as well as product qualification tests. Responsibilities · Create equipment and software specifications for testing product and performance requirements ie […]

QC Supervisor – Southern MA – Medical Device Company

SCOPE: This job description outlines the general duties and responsibilities of the Quality Control Supervisor position. DUTIES AND RESPONSIBILITIES: ·To supervise all assigned quality inspection personnel in a manner which represents the standards and goals of the company. To know, understand and comply with all company policies directed by the company policy manual. o Require […]