Job Title

Scientific & Clinical Job Details

Regulatory Affairs Specialist

Job Code: #706
Job Type: Contract
Salary: $42.00 - $47.00/hour
Job Location: Lake Zurich, IL
Posted 2 days ago

Job Description

Job Title:  Regulatory Affairs Specialist 

Pay:  $42.00 - $47.00/hour

Job Overview:  Implement policies and coordinate community affairs strategies.  Develop and maintain supportive relationships with regulatory bodies.

Responsibilities
• Compile and maintain regulatory documentation databases or systems.
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Analyze product complaints and make recommendations regarding their reportability.
• Develop or conduct employee regulatory training.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

Requirements:
• Bachelors degree in related field desired.
• 2-4 years of experience.
• Verbal and written communication skills, attention to detail, customer service and interpersonal skills.
• Ability to work independently and manage one’s time.
• Knowledge of legal policies and procedures related to hiring practices (i.e., equal employment opportunity and affirmative action).
• Knowledge of benefit and pay-scale systems.
• Previous experience with computer applications, such as Microsoft Word and Excel.