Job Information
Belimed Inc. Quality & Regulatory Manager (Medical Device/Equipment) in United States
Quality & Regulatory Manager (Medical Device/Equipment)
Your tasks
As the Quality and Regulatory Manageryou will be responsible for quality control, quality assurance and regulatory affairs for the U.S. business unit.
How you will impact Belimed and our clients
Implement the worldwide Belimed Quality Policy and derive appropriate programs and systems to support strategic direction and conduct training on those systems
Analyze quality/regulatory information for current and prospective products and presents findings to local management and global counterparts
Manage cases in the CAPA Management System regarding documentation quality, time deadlines and efficacy of Corrective and Preventive Actions
Support the operation of the CAPA Management System and understand the meaning of Non-Conformance handling processes such as audit findings, non-conformance, complaints, investigations, and reportable incidents
Track quality/regulatory training of all employees via standardized document control forms (QMS document control)
Ensure the U.S. business complies with the requirements of ISO 13485 by managing the Integrated Management System (IMS)
Partner with management to formulate and establish business improvement activities/goals that are accomplished within prescribed time frame and cost parameters
Conduct supplier and internal audits
Act as U.S. representative during on-site FDA inspections
Act as the regulatory contact person for U.S. product and material related requirements
Act as U.S. representative for FDA registration of the organization (importer role)
Review technical publications, articles, and abstracts to stay abreast of technical developments in industry
Analyze, evaluate and present (monthly/quarterly/annually) reported and responsible Quality Issues status and history
Attend and actively participate in quality/regulatory professional associations
Update and improve business processes
Drive a continuous improvement culture within the US organization to include:
Lead cross-functional Continuous Improvement events using DMAIC model
Lead and train value stream mapping exercises to define processes
Work with the site to implement or streamline/improve use of LEAN tools, 5S, Six SIGMA, etc
Support process owners in making recommendations for updating/improving the Integrated Management System (IMS)
Act as key user for SAP Enable Now (SEN)
Act as Business Analyst for Belimed US Quality & Regulatory
What you need to succeed
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
APPLY ONLINE NOW (http://recruitingapp-2806.umantis.com/Vacancies/5751/Application/CheckLogin/2)
As a full-time team member, you will be eligible for our excellent benefits package to include medical, dental, vision, life and disability insurances, 401(k) with a company match, multiple paid time off programs, flexible work from home options and more!
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. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. EOE
Resume submittals from individual recruiters or third party recruiting agencies are not approved for this opportunity at this time.