Regulatory Affairs Specialist II

Job Summary:

The Regulatory Affairs Specialist II will be responsible for the creation, preparation and coordination of regulatory submissions and approvals to introduce new orthopedic implant products in the domestic and international markets. This includes interpretation of relevant government regulations.

 

 

Essential Duties and Responsibilities:

  • Develop and maintain strong, internal working relationships across ConforMIS.
  • Understand the objectives, responsibilities, and mission of the Regulatory 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.
  • Draft responses to regulatory agencies and notified bodies as part of the submission and approval processes.
  • Maintain regulatory files/database and chronologies in good order.
  • 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 3-5 years of relevant industry experience.
  • Experience with FDA/EU 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.
  • Demonstrated 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.
  • Strong problem solving and judgment skills.
  • Excellent 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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