Compliance Specialist

Compliance Specialists manage their organization's need to obey regulations such as grant requirements, or local, state or federal laws regulating the industry.  This person may be responsible for preparing regulatory submissions for drugs, biologics and medical devices.

Fast Facts & Skills

Details

Education & Training: 

Requirements: 

  • Requires a bachelor’s degree in a science or engineering related discipline, and 2 years of experience in a regulated environment (GMP)
  • Strong written and oral communication skills; ability to communicate effectively in a team environment 
  • Must have strong written skills with basic knowledge and interest in IT 
  • Must be proficient in Microsoft Office and Windows operating systems 
  • Ability to take initiative and prioritize tasks; good time-management, problem-prevention, and problem-solving skills 
     

Compliance Specialists manage their organization's need to obey regulations such as grant requirements, or local, state or federal laws regulating the industry.  This person may be responsible for preparing regulatory submissions for drugs, biologics and medical devices.  Compliance specialists may spend time meeting with scientists, writing and reviewing documents, presenting information about updates to regulations and discussing strategies to ensure compliance. 

Compliance specialists often leading deviation investigations and manage Corrective and Preventive Actions (CAPAs) to maintain the highest levels of product quality and regulatory compliance.

Where to Work and Learn

Example Employers: 

InnovATEBIO programs offer degrees, certificates, or teach skills in these related areas.

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