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

Belimed; Louisiana; 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. business unit. This role involves implementing quality policies, managing compliance with ISO standards, and conducting audits. The position requires strong leadership skills and the ability to travel for audits and training. Join a dynamic team dedicated to enhancing patient safety and health, while enjoying a comprehensive benefits package that supports your well-being and professional growth.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with Company Match

Paid Time Off

Flexible Work Options

Qualifications

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

Responsibilities

• Implement the Belimed Quality Policy and develop training programs.
• Manage CAPA system operations and ensure compliance with ISO 13485.
• Conduct supplier and internal audits while representing the organization in FDA processes.

Skills

Quality Management Systems

Regulatory Affairs

Process Management

Public Speaking

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 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

1. Implement the worldwide Belimed Quality Policy, develop programs and systems, and conduct training.
2. Analyze quality/regulatory data for current and prospective products, presenting findings to management.
3. Manage cases in the CAPA Management System concerning documentation quality, deadlines, and effectiveness of corrective actions.
4. Support CAPA system operations and handle processes like audits, non-conformance, complaints, investigations, and incidents.
5. Track employee training via standardized document control forms.
6. Ensure compliance with ISO 13485 by managing the Integrated Management System (IMS).
7. Collaborate with management on business improvement activities within set time frames and budgets.
8. Conduct supplier and internal audits.
9. Serve as the regulatory contact for U.S. product and material requirements.
10. Represent the organization in FDA registration processes.
11. Stay updated on industry developments through publications and abstracts.
12. Report and analyze quality issues regularly.
13. Participate in professional associations related to quality and regulatory affairs.
14. Improve and update business processes.
15. Lead continuous improvement initiatives using DMAIC, value stream mapping, and lean tools like 5S and Six Sigma.
16. Support process owners in IMS updates and improvements.
17. Act as a key user for SAP Enable Now and as a Business Analyst for US 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.
• At least six years of experience with Quality Management Systems, including ISO 13485.
• Experience in public speaking and presentations.
• Excellent English verbal and written 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 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 of any kind in all employment practices.