Overview
Quality & Regulatory Manager – Medical Device/Equipment/Remote Jobs in Fort Wayne, Indiana, USA at Belimed
Position: Quality & Regulatory Manager – Medical Device / Equipment (Remote with travel)
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 over 50 years of history. Our presence includes offices in 9 countries and representation in over 80 countries through a strong network.
We believe that great teams are the key to our success. At Belimed, you will work in an international environment with talented people dedicated to improving patient and medical staff safety and health.
Quality & Regulatory Manager – Medical Device / Equipment (Remote with travel)
Your tasks
As the Quality and Regulatory Manager, you will be responsible for quality control, quality assurance, and regulatory affairs for the U.S. business unit.
This role requires approximately 30 days of travel annually, including visits to our South Carolina headquarters, customer sites across the US, and periodic visits to Europe.
How you will impact Belimed and our clients
Implement and support the worldwide Belimed Quality Policy, including training programs
Analyze quality/regulatory information for current and prospective products and present findings
Manage CAPA cases related to documentation quality and corrective actions
Support operations of the CAPA Management System and handle non-conformance processes
Monitor and document quality/regulatory training for employees
Ensure compliance with ISO 13485 through the Integrated Management System (IMS)
Collaborate with management on business improvement activities
Conduct supplier and internal audits
Serve as the regulatory contact for U.S. product requirements
Represent the organization for FDA registration and importation roles
Stay informed on industry developments through publications and abstracts
Report and analyze quality issues periodically
Participate in professional associations
Update and improve business processes
Lead continuous improvement initiatives using DMAIC, Lean, 5S, Six Sigma tools
Support process owners in IMS improvements
Act as key user for SAP Enable Now (SEN) and as Business Analyst for Quality & Regulatory
What you need to succeed
Bachelor’s degree in Engineering or Business Administration
At least four years of experience working with regulators in the medical industry
Minimum of eight years in process management, including training and coaching
Extensive experience with Quality Management Systems, especially ISO 13485
Public speaking and presentation skills
Excellent English communication skills
Proficiency in MS Office Suite
Ability to travel quarterly to Charleston HQ and obtain a valid passport for international travel
As a full-time team member, you’ll be eligible for benefits including medical, dental, vision, life and disability insurances, 401(k) with a company match, paid time off, flexible work options, and more.
Belimed is an equal opportunity employer, committed to diversity and inclusion in the workplace, prohibiting discrimination and harassment of any kind.
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Title: Quality & Regulatory Manager – Medical Device/Equipment/Remote
Company: Belimed
Location: Fort Wayne, Indiana, USA
Category: Quality Assurance – QA/QC
