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Regulatory Affairs Specialist

Company: Sheathing Technologies, Inc
Location: Morgan Hill
Posted on: August 4, 2022

Job Description:

Regulatory Affairs SpecialistSheathing Technologies, Inc., founded in 1992, is a medical device manufacturer of Ultrasound Probe Covers, FDA-Cleared Viral Barriers, Adhesives, Needle Guides Kits, Ultrasound Gel, and Storage/Transport Covers. We are the global leader of infectious control solutions. We are proud of the fact that more than 90% of our products are manufactured in the United States with the bulk of it right in our facility located in Morgan Hill, CA. As market leaders, our technological advancements for ultrasound procedures have enabled us to continually increase quality, year after year. We are looking to expand our team and are now accepting applications for a Regulatory Affairs Specialist.Our biggest accomplishment in recent history has been to develop and create the world's only FDA cleared Viral Barrier which provides the safest ultrasound guided procedures. This product provides our clinicians and their patients with a complete barrier to all bacteria, and all currently known testable viruses.Sheathing Technologies, Inc. is committed to providing a comprehensive benefits package to all of the company's employees. We offer standard benefits such as medical, dental, and optional vision coverage, life insurance, 401(k) matching plan & tuition reimbursement. The benefits offered by Sheathing Technologies, Inc. is designed to positively impact all aspects of your life; to help you and your family succeed and to maintain our status as a "perfect job". Come find out what Sheathing Technologies, Inc. has to offer you.As a Regulatory Affairs Specialist in our Morgan Hill, CA facility you will be responsible for:

  • Represents Regulatory Affairs on cross functional teams and in interactions with other departments
  • Assists with communication with FDA and other regulatory bodies, including submissions and audits
  • Manage MDD/MDR compliance activities and Technical File maintenance
  • Creates regulatory strategies and polices for new products in cooperation with new product development
  • Assist in qualification and validation of new equipment
  • Support product release and other related QA functions as needed
  • Provides guidance to Quality Assurance team members on regulatory requirements
  • Oversee the Environmental Monitoring Program by facilitating testing with external vendors
  • Consults with senior management on regulatory decisions
  • Determines resolution of technical problems and communicate RA expectationsQualifications:Education: BS/BA in Science, Engineering, or Regulatory Affairs/Quality AssuranceExperience:
    • Expertise in FDA quality system regulations for non-critical medical device
    • 5 or more years of experience in QA/RA at a medical device company under ISO13485 and 21 CFR
    • Expertise in Regulatory Affairs for medical devices strongly preferred
    • Thorough knowledge and understanding of US and International Medical Instrument Regulations
    • Experience with 510(k) submissions and EU Regulations
    • Demonstrated experience and technical understanding of development, manufacturing, and quality assurance processes for non-critical medical devices
    • Experience with electronic documentation systems desirable
    • Knowledge of ERP systemSkills:
      • MS Office proficient (Excel, Word, PowerPoint, Outlook)
      • Demonstrated effective verbal & written communication skills
      • Proven problem-solving skills in a teamwork settingSalary - Commensurate with experience

Keywords: Sheathing Technologies, Inc, Mountain View , Regulatory Affairs Specialist, Other , Morgan Hill, California

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