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

Belimed; Tennessee; Remote; USD 95,000 - 125,000; Full time

Job summary

Belimed, a leading supplier in medical instrument sterilization, is seeking a Quality & Regulatory Manager. This remote role with travel entails overseeing quality control and regulatory affairs, supporting compliance with ISO 13485, and managing audits. Ideal candidates have significant experience in the medical industry and possess strong communication and process management skills.

Benefits

Comprehensive benefits package

401(k) with company match

Flexible work options

Qualifications

• At least 4 years working with regulators in the medical industry.
• At least 8 years in process management, including training and coaching.
• At least 6 years of experience with Quality Management Systems, including ISO 13485.

Responsibilities

• Implement and support the worldwide Belimed Quality Policy and related programs.
• Analyze quality/regulatory information for current and prospective products.
• Manage CAPA cases to ensure documentation quality and effectiveness.

Skills

Public speaking

Presentation skills

Excellent English communication

Proficiency in MS Office

Education

Bachelor’s degree in Engineering or Business Administration

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. We operate in 9 countries and are represented in over 80 countries through a strong network.

We believe that great teams are 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 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 and related programs, including staff training
• Analyze quality/regulatory information for current and prospective products, presenting findings to management
• Manage CAPA cases regarding documentation quality, deadlines, and effectiveness of corrective actions
• Support CAPA system operations and handle audit findings, non-conformance, complaints, investigations, and incidents
• Monitor and document quality/regulatory training for all employees
• Ensure compliance with ISO 13485 through management of the Integrated Management System (IMS)
• Collaborate with management on business improvement initiatives within time and budget constraints
• Conduct supplier and internal audits
• Serve as the regulatory contact for U.S. product and material requirements
• Act as the U.S. representative for FDA registration (importer role)
• Stay informed on industry developments through publications and abstracts
• Report on quality issues periodically and analyze trends
• Participate in professional associations related to quality and regulatory affairs
• Update and enhance business processes
• Lead continuous improvement activities using DMAIC, lean tools, 5S, Six Sigma, etc.
• Support updates to the IMS and act as a key user for SAP Enable Now
• Serve as Business Analyst for US Quality & Regulatory

What you need to succeed

• Bachelor’s degree in Engineering or Business Administration
• At least 4 years working with regulators in the medical industry
• At least 8 years in process management, including training and coaching
• At least 6 years of experience with Quality Management Systems, including ISO 13485
• Public speaking and presentation skills
• Excellent English communication skills
• Proficiency in MS Office
• Ability to travel quarterly to Charleston HQ and internationally as needed

As a full-time employee, you will be eligible for our comprehensive benefits package, including medical, dental, vision, life and disability insurances, 401(k) with company match, paid time off, flexible work options, and more.

Belimed, Inc. is an equal opportunity employer, committed to diversity and prohibits discrimination and harassment in all employment practices.