logo

View all jobs

Regulatory Affairs Specialist - Medical Devices

Mchenry, IL
ESSENTIAL FUNCTIONS
  • Consultancy and support of project teams during the development of new products and the product lifecycle in terms of questions in regards to risk management, products safety licensing as well as standards and guidance documents
  • Advise project team members on data and information required for successful license applications and coordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission
  • Independent review of technical documentation according to specific international laws and guidance documents relevant for medical devices
  • Establishment and maintenance of the Regulatory Process related documentation within the product lifecycle
  • Maintenance of the product licenses for the relevant markets
  • Responsible for routine operations including, but not limited to, label reviews, marketing literature reviews, and regulatory support for customers, sales channel and internal personnel.
  • Researches regulations, and obtains regulatory updates from professional organizations and government agencies
  • Works on assigned projects as allocated by the Regulatory Affairs Manager
  • Researches Federal, State and local regulations governing the manufacture, promotion, distribution, disposal and export of company products
  • Communicates current and upcoming regulations to appropriate internal and sales channel personnel, when necessary
  • Maintains an understanding of the documentation required to support the import and export of products, parts and accessories
  • Responds to vendor, sales agent, and customer inquiries regarding regulatory issues
  • Attends internal meetings to represent the Regulatory Affairs Department
  • Reviews marketing literature to ensure regulatory compliance
  • Reviews labeling for conformance with applicable regulations (FDA, FTC, NIST, etc), edits and approves such labeling as necessary and when designated
  • Reviews Design History Files and Technical Files of products for completeness and accuracy, when required
  • Complies with all federal, state, and local laws and regulations
  • Follows all Company rules and regulations, including health and safety rules
  • Successfully interacts with employees at all levels
  • Regular, reliable performance of all job duties
  • Travel as may be required to meet business expectations
  • Performs all other duties as assigned or as may be required from time to time

EDUCATION and CRITICAL SKILLS/EXPERIENCE
  • Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline
  • Minimum 3-5 years regulatory affairs experience required

  • Regulatory Affairs Certification (RAC) preferred
  • Knowledgeable of 21 CFR 801 and, 820
  • Knowledgeable of FDA guidelines and ISO standards for Medical Devices
  • Knowledgeable of foreign regulations for medical devices
  • Knowledge of technical standards (e.g. IEC 60601, IEC 62366)
  • Must possess accuracy; strong attention to detail; solid written and oral communication skills; ability to prioritize projects and work independently; and excellent organizational skills
  • Ability to read and understand complex technical, legislative and regulation information and make independent decisions
  • Excellent verbal and written communication skills
  • Excellent ability to organize and manage information
  • Ability to manage multiple conflicting priorities
  • Experience working in an environment with global objectives

LANGUAGE/REASONING SKILLS
  • Must be able to read, understand and communicate in English
  • Apply principles of logical thinking to solve practical problems

PHYSICAL DEMANDS 
  • Travel  5% of the time, including occasional international travel
  • Must be able to occasionally lift and/or move up to 10 pounds

ENVIRONMENTAL CONDITIONS 
  • Indoors, average office environment with little exposure to excessive noise, dust, or temperature changes
====================================================
LEE WEBER GROUP--Placing you in a Better Future
Visit us on the web
 at 
http://www.leewebergroup.com 
====================================================

Office: 859-296-1112
Email: mail@leewebergroup.com
Fax: 859-296-0050
 
Powered by