Regulatory Specialist 2

RTI Surgical
Job Description
Position Summary:
This position will be responsible for analyzing and supporting/resolving functional business issues and needs, as well as meeting assigned performance objectives, completing assigned tasks, and achieving set metrics in area of specialization.  The Specialist will ensure adherence to company policy and procedures, and will assist in maintaining quality control processes throughout RTI Surgical.  This position will help RTI Surgical maximize the amount of patients served while maintaining a high level of quality and safety through the support of the business functions.     
 
Responsibilities:
  • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
  • Authors regulatory submissions (e.g., 510(k) in collaboration with a cross-functional team
  • Reviews and approves labeling, advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
  • Responsible for supporting assigned department or function while acting as a liaison to internal and external customers
  • Participates and assists in internal and external requests.  Assists in immediate action and correction of operational and customer services issues and complaints
  • Responsible for ensuring assigned metrics are maintained; which may also include preparing, tracking, and trending reports, conducting audits and providing timely feedback to stakeholders
  • Develop and maintain effective working relationships with RTI management team and staff to support needs of the business and ensure requested information is obtained timely, is complete and accurate
  • Support company and departmental quality and business objectives and initiatives
  • Other duties as assigned
Education/Experience Required:
  • Bachelor’s degree (or non-US equivalent) in relevant technical discipline (Engineering, Science, or medically related) required.
  • 3+ years relevant medical device or pharmaceutical regulatory experience
  • Regulatory Affairs Certification (RAC) and AATB CTBS preferred.
  • A combination of education and experience may be considered
Knowledge, Skills, Abilities:
  • Strong writing, communication, and interpersonal skills
  • Strong attention to detail; ability to multi-task and balance competing priorities
  • Knowledge of FDA, EU, and other regulatory body regulations
 
 
Physical Requirements:
 
Light work:  Physically handle objects up to 20 lbs. occasionally.
 
Work Environment:
Office Setting - Open layout with assigned work station or office
Contact Information