Sr. Regulatory Affairs Specialist

Job Summary:

The Senior Regulatory Affairs Specialist (International) will be responsible for US and International product submission/ registration activities.  This includes interpretation of relevant government regulations and assisting in establishing compliance to these regulations.

Essential Duties and Responsibilities:

  • Develop and maintain strong, internal working relationships across ConforMIS.
  • Understand the objectives, responsibilities, and mission of the Regulatory Affairs department and works towards those goals.
  • Prioritize and plan work activities; adapt for changing conditions.
  • Responsible for establishment registration and device listing
  • Understand and interpret the regulatory Requirements in various geographies.
  • Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval processes.
  • Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies.
  • Review labeling and advertising/promotional materials for compliance with regulatory requirements.
  • Understand, interpret and implement regulatory requirements for medical devices that may contain software.
  • 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.
  • Review and approve Engineering Change Orders in accordance with regulatory requirements.
  • Assist in regulatory compliance activities.
  • Coordinate and conduct Internal Audits.
  • Other responsibilities as assigned.

Qualifications:

  • Bachelor’s degree in Engineering or Science. Advanced degree preferred.
  • Minimum 5+ years of relevant industry experience.
  • 3+ years’ experience with FDA/EU/ROW submissions.
  • Knowledge of applicable regulatory requirements.
  • Regulatory compliance experience in the medical device area preferred.
  • RAC certification desired.

Skills, Abilities, and Competencies Required:

  • Excellent written and verbal communication skills.
  • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
  • Demonstrates ability to monitor own work to ensure quality, accuracy and thoroughness.
  • Strong organizational, analytical and time-management skills.
  • Able to self-motivate and work both independently and as part of a team.
  • Demonstrates excellent problem solving and judgment skills.
  • Meets timelines and drives regulatory process.
  • Proficient understanding of regulations and guidelines for related to the development, manufacturing and labeling of medical devices with emphasis on software containing medical devices.
  • ConforMIS is an Equal Opportunity Employer
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