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Synectics

Clinical Regulatory Affairs Associate

Post Date:Apr 21, 2017Type:Full-Time
Start Date:4/21/2017Salary:
Location:US-IL-Lake Forest Job Reference:1DCB42-Sy##
Skills:

Minimum Education/Experience:

  • Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred.
  • 2+ years’ experience in a regulated industry (e.g., medical products, nutritional). This position does not require previous regulatory experience. Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.


Job Description:

Primary Job Description:

  • The individual will support registration of in vitro diagnostic assays by reviewing and approving verification study reports, package insert/labeling, technical files and other documents, and submitting documentation on schedule as directed.
  • As an individual contributor; the function of a Regulatory Affairs Associate is to provide support for regulatory processes and procedures. The individual may execute tasks and exercise influence generally at the peer level.

 

Core Job Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 
  • Assist in SOP development, review and initiation
  • Stay abreast of regulatory procedures and changes in regulatory climate and update department
  • Investigate regulatory history of similar products to assess approval implications
  • Assist in monitoring and reporting project timelines
  • Respond to regulatory information requests
  • Monitor and utilize tracking and control systems
  • Organize materials from preclinical and clinical studies for review and assist in review process
  • Compile and organize materials for pre-submission reports
  • Coordinate and assist in the preparation of submission/registration packages
  • Coordinate registration requests and track completion
  • Oversee quality control of regulatory documents and submissions
  • Organize meetings with regulatory agency staff
  • Update and maintain global product listings; facility registrations; licenses/approvals; and annual registrations
  • Assist in the preparation of routine reports and regulatory agency communications
  • Update and maintain paper/electronic document archival systems
  • Prepare legal documents for import/export, registrations, tenders/bids or other purposes
  • Assist with review of promotional items
  • Coordinate internal audits and inspections
  • Assist with global vigilance reporting and regulatory field actions such as recalls or corrections & removals
  • May provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
  • Coordinate and support technical and scientific regulatory activities, research regulations and guidance and maintain and organize key information sources.
  • Works under general supervision, receives limited supervision on standard issues and detailed instructions on new assignments. Work is reviewed for soundness of judgment, overall adequacy and accuracy.

 

Since 1984, Synectics has been committed to aligning talented professionals with jobs they find

challenging and fulfilling. Let us leverage our recruiting experience and our long-standing relationships with our clients to help you in your job search.

 

To view a comprehensive list of jobs offered by Synectics, please visit our website at www.synectics.com. We offer a wide variety of positions in cities throughout the United States.

 

Synectics is an Equal Opportunity Employer.

 

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Contact Information
Synectics
Name: recruiter
Ph: 312-629-1020
FAX: 312-629-1028


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