Quality and Regulatory Manager

1 month ago

Minnesota, United States Belimed Full time
Job Title: Quality and Regulatory Manager

Belimed is a leading supplier of medical and surgical instrument sterilization, disinfection, and cleaning products and services. We are headquartered in Zug, Switzerland, and have a strong presence in the global market.

Your Key Responsibilities:
  • Implement and maintain quality control and quality assurance processes for the U.S. business unit.
  • Manage regulatory affairs and ensure compliance with FDA regulations and ISO 13485 standards.
  • Develop and implement business improvement activities and goals that align with the company's strategic direction.
  • Conduct supplier and internal audits, and act as the U.S. representative during on-site FDA inspections.
  • Partner with management to formulate and establish business improvement activities/goals that are accomplished within prescribed time frame and cost parameters.
  • Review technical publications, articles, and abstracts to stay abreast of technical developments in the industry.
  • Update and improve business processes, and drive a continuous improvement culture within the US organization.
Requirements:
  • Bachelor's degree in an Engineering related field or business administration.
  • Minimum four years working with regulators in the medical industry.
  • Minimum eight years of process management experience including training, development and coaching.
  • Minimum six years of experience with the use and implementation of Quality Management Systems.
  • ISO 13485 Quality System experience.
  • FDA QSR regulations experience (21CFR820 etc.).
  • Public speaking and/or presentation experience.
  • Excellent verbal and written skills in the English language.
  • Experience in MS Office Suite.
  • Ability to travel to the Charleston HQ on a quarterly basis.
  • Able to obtain a valid passport for occasional international travel.
What We Offer:

Belimed, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex (including pregnancy, gender identity or expression, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit based factors.

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