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.