JOB POSITION PURPOSE

As an individual contributor, the function of the Regulatory Affairs Specialist   is to support the Regulatory Affairs Department ensuring compliance with company standards and the applicable US and international medical device/drug regulations in which the company does business. The individual will prepare product submission documentation, evaluate design/manufacturing changes for effects on regulatory filings, and provide guidance to project teams as it relates to application of regulatory requirements.  The individual will execute tasks and play a consultative role by partnering across internal business functions.  The individual may also have/lead discussions with Regulatory Bodies.

ROLES AND RESPONSIBILITIES

• SOP development and review
• Lead development of regional regulatory strategy and update strategy based upon regulatory changes with limited supervision
• Determine and communicate submission and approval requirements
• May participate in risk-benefit analysis for regulatory compliance
• Understand business environment
• Self-motivated and willingness to learn and proactively problem solve
• Ability to work an 8 hour day
• Understanding compliance to Corporate and Regulatory procedures/ requirements and goals
• New product registrations, assessing changes to existing registrations, and maintaining registrations current for assigned products/geographies
• Demonstrate a strong degree of knowledge in excel spreadsheet maintenance, use of outlook tools, sharepoint, SAP based systems, and other computer programs used for tracking and reference.  
• Maintain records and documents for established systems that support regulatory activities and requirements.
• Strong attention to detail, highly organized, and able to manage multiple projects simultaneously.
• Lead projects/initiatives.
• Develop and remain current on applicable internal procedures/process(s) and applicable regulations (US and INTL).

REQUIRED QUALIFICATIONS

EDUCATION: A Bachelor´s degree in a relevant discipline

EXPERIENCIE: 2-6 years of experience in the medical device industry and/or Regulatory Affairs for medical devices. 

ENGLISH: Advanced