Quality & Regulatory Manager - Medical Device / Equipment (Remote with travel)

Belimed; Fort Wayne (IN); Remote; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Quality & Regulatory Manager to oversee quality control and regulatory affairs for its U.S. operations. This pivotal role involves ensuring compliance with ISO 13485, managing CAPA cases, and conducting audits. The ideal candidate will possess a strong background in Quality Management Systems and regulatory processes within the medical sector. With the opportunity to work remotely and travel, this position offers a unique chance to contribute to the safety and health of patients and medical staff. Join a dynamic team dedicated to continuous improvement and excellence in quality management.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with Company Match

Paid Time Off

Flexible Work Options

Qualifications

• 4+ years of experience with regulators in the medical industry.
• 8+ years in process management, including training and coaching.

Responsibilities

• Implement and support the worldwide Belimed Quality Policy.
• Manage CAPA cases and ensure compliance with ISO 13485.
• Conduct supplier and internal audits.

Skills

Quality Management Systems

ISO 13485

Public Speaking

Presentation Skills

Process Management

Communication Skills

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Business Administration

Tools

SAP Enable Now

MS Office Suite

Job description

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.