Sr. Regulatory Affairs Specialist

Posted for ConforMIS, Inc. on January 23, 2012

 

 TITLE:  Senior Regulatory Affairs Specialist

 

                                                               CLICK HERE TO APPLY or go to www.conformis.com

 ConforMIS, Inc. is a privately held medical device company based in Burlington, Massachusetts. It was founded in 2004 to provide dramatic advancements in patient care by utilizing imaging technology to create personalized, patient-specific implants and instrumentation.

 Job Summary:

  This position is primarily responsible for US and International software-related product submission/registration activities. This includes interpretation of relevant government regulations and assisting in establishing compliance to these regulations.

 Essential Duties and Responsibilities:

  • Understand, interpret and implement regulatory requirements for medical device software
  • Participate in software lifecycle development process and provide regulatory input to software verification and validation planning
  • Work with programmers and software engineers to prepare software documents in accordance with regulatory guidelines
  • Draft and review software test protocols and reports required for regulatory submissions
  • Participate in the software risk analysis process and ensure documentation per regulatory guidelines
  • Prepare document packages for regulatory submissions including  510(k)s and Design Dossiers
  • Track and coordinate regulatory submission activities to ensure timelines and commitments are met
  • Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval processes.
  • Review and approve Engineering Change Orders in accordance with regulatory requirements
  • Review device labeling and advertising material for compliance with submissions and regulations
  • Assist in regulatory compliance activities
  • Other duties as assigned

 Qualifications:

  • Bachelor’s degree in Engineering or Science. Advanced degree preferred.
  • Proficient in software development process
  • Prior experience in as software QA testing preferred
  • Minimum 5+ years of relevant industry experience
  • 3+ years’ experience with FDA and EU submissions
  • Knowledge of applicable regulatory requirements
  • Experience in software submissions required
  • Regulatory compliance experience in the medical device area preferred
  • RAC certification desired

 Skills, Abilities, Competencies Required:

  • Excellent communication skills both written and verbal
  • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.
  • Proficient understanding of regulations and guidelines for related to the development, manufacturing and labeling of medical devices with emphasis on software containing medical devices
  • Ability to multitask and, work independently and handle complex tasks with great attention to detail
  • Demonstrates excellent problem solving and judgment skills
  • Meets timelines and drives regulatory process

 

ConforMIS is an Equal Opportunity Employer