Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

Regulatory Affairs Associate

Job Code: #594
Job Type: Contract
Salary: $22.00 - $27.00/hour
Job Location: Lake Zurich, IL
Posted 7 days ago

Job Description

Job Title:  Regulatory Affairs Associate

Pay:  $22.00 - $27.00/hour

Job Overview: 
  • Collaborate with international colleagues to generate high quality submission dossiers to obtain medical device approvals in international markets.
  • Gather design and development information on products from cross-functional teams and submit on-time renewal applications to maintain existing registrations worldwide.
  • Develop regulatory strategies for countries outside of U.S to ensure speed to market while maintaining high standards of quality.
  • Assess global impact of product changes such as manufacturing, design, materials, technology, labeling etc. to determine course of action and develop regulatory strategy for implementation of such changes.
  • Conduct research on applicable product standards and guidance documents issued by health authorities worldwide and determine impact of proposed and current global regulations to propose suggestions for expediting approvals.
Requirements:
  • Previous experience in a Regulatory environment desirable.
  • Pharmaceutical or Medical Device experience preferred.
  • Experience in preparing domestic and international product submissions.
  • Knowledge of US, EU and international regulatory requirements.
  • Experience with design and development of medical devices.
  • Ability to manage multiple projects and deadlines and communicate priorities effectively.
  • Experience evaluating information to determine compliance with standards, laws, and regulations.
  • Well-developed oral and written communication skills.
  • Bachelor's Degree preferred.
  • Ability to grasp new concepts quickly and to assimilate and evaluate scientific data.
  • Great team-player showcasing ability to work in a collaborative culture.
  • Portray critical thinking to understand complex information and convert/communicate it in a comprehensible manner. 
  • Organize data packages in a clear and concise manner to enable smooth reviews of scientific information by external stakeholders.