Associate, Clinical Research in Westford, MA at Volt

Date Posted: 9/3/2020

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Westford, MA
  • Job Type:
  • Duration:
    20 weeks
  • Date Posted:
    9/3/2020
  • Job ID:
    241429
  • Contact Name
    Volt Branch

Job Description

Clinical Research Associate

This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.

  • Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
  • Creates, reviews and approves engineering changes.
  • Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
  • Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international
  • affiliates.
  • Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.
  • Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • May interface directly with FDA and other regulatory agencies if so directed.
  • Reviews protocols and reports to support regulatory submissions.
  • Supports all business segment initiatives as identified by divisional management and in support of Quality Management
  • Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

  • BS in engineering/scientific discipline and 1-2 years of relative experience.

Volt is an equal opportunity employer.