Regulatory Affairs Specialist

Company: Kelly
Location: Schaumburg
Posted on: November 12, 2021

Job Description:

Kelly Services is actively recruiting for a Regulatory Affairs Specialist for a Direct Hire opportunity in Greater Chicago area, IL. Kelly is seeking a Regulatory Affairs Specialist to join the Regulatory department. The Regulatory Affairs Specialist is responsible for supporting the preparation of regulatory submissions and assisting international business partners with product registrations; preparation of technical files; provide change notifications to foreign distributors and notified bodies; provides regulatory support to lifecycle management and new product development/new product introduction and international product registrations. In This Position You Will Use Your Experience To

• Under supervision, coordinate, compile, and submit regulatory documents to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files.
• Work with Manager, Regulatory Affairs to ensure rapid and timely approval of new products and continued regulatory support of products marketed outside the United States
• Work to support and ensure regulatory compliance across LATAM region for a broad product portfolio including medical devices, consumer packaged goods, drugs and cosmetics.
• Assist with the development of the LATAM regulatory strategy collaborating with appropriate functional partners and contribute to business strategy.
• Support and make recommendations for projects by working closely with LATAM functional partners and Manager Regulatory Affairs to move projects from discovery to launch.
• Under supervision, evaluate proposed product modifications for international regulatory impact, completing regulatory assessments as needed.
• Ensure compliance with applicable international regulations and standards
• Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Under supervision, prepare responses to health authority questions and other regulatory correspondence.
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
• Update and maintain FDA/Health Canada Establishment Registration and Listing, as well as State licensing
• Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.
• Review and approve promotional materials. The Ideal Candidate Will Possess
  • Bachelor's Degree in Science/Technology required
  • Minimum of 2 years of related experience with Medical Devices
  • Direct experience with international medical device/cosmetic/drug registration (especially Brazil, Colombia, Argentina, Mexico, Canada and Europe) is desired
  • Minimum 1 year of experience with 21 CFR 820, 807, 11, 701; ICH, ISO 13485:2016 and ISO 14971
  • Familiarity with application of US Federal Food, Drug, and Cosmetic Act (FD&C), Section 510(k) is required.
  • Experience in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is required; EU MDR familiarity is desired.
  • Working knowledge of Regulatory Authority computerized submission systems
  • Solid writing ability and good verbal communication skills
  • Proficiency in MS Office
  • Good interpersonal and organizational skills Benefits
    • Comprehensive insurance coverage that includes Medical, Vision, Life and disability insurance plans along with enhanced Dental benefits.
    • Wellness program including an onsite fitness center.
    • 401K retirement plan with 5% employer match (Pretax and Roth options)
    • 401k profit sharing contribution based on company performance
    • Paid holidays and generous paid time off.
    • Competitive annual bonus and sales incentive programs Employee Perks
      • On-site caf-- featuring daily specials with dinner-to-go options
      • Miles of beautifully maintained walking trails.
      • Numerous employee appreciation events throughout the year.
      • Professional development and training classes
      • Flexible schedule including work from home options If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life. #TJP2021_SPEC Why Kelly -- ? Kelly-- Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly -- At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]

Keywords: Kelly, Schaumburg , Regulatory Affairs Specialist, Other , Schaumburg, Illinois