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

Belimed; Kansas; Remote; USD 85,000 - 110,000; Full time

Job summary

A leading supplier of medical and surgical instrument sterilization is seeking a Quality & Regulatory Manager. This remote role involves managing quality control and regulatory affairs for the U.S. business unit, requiring travel and collaboration with global teams. Ideal candidates will have extensive experience in quality management systems and regulatory compliance, along with strong communication skills.

Benefits

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with company match

Paid time off

Flexible work options

Qualifications

• 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.

Responsibilities

• Implement the worldwide Belimed Quality Policy and develop programs.
• Manage cases in the CAPA Management System related to documentation quality.
• Serve as the regulatory contact for U.S. product and material requirements.

Skills

Public speaking

Presentation skills

Excellent English communication

Process management

Education

Bachelor’s degree in engineering or business administration

Tools

MS Office Suite

SAP Enable Now

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, with over 50 years of history, offices in 9 countries, and a presence 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 the safety and health of patients and medical staff.

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 involves approximately 30 days of travel annually, including visits to our South Carolina headquarters, customer sites across the US, and periodic trips to Europe.

How you will impact Belimed and our clients

1. Implement the worldwide Belimed Quality Policy and develop programs and systems to support strategic goals, including conducting training on those systems.
2. Analyze quality and regulatory information for current and prospective products, presenting findings to local management and global teams.
3. Manage cases in the CAPA Management System related to documentation quality, deadlines, and efficacy of corrective and preventive actions.
4. Support CAPA system operations and understand processes like audit findings, non-conformance, complaints, investigations, and reportable incidents.
5. Track employee training related to quality and regulatory compliance using standardized documentation.
6. Ensure U.S. compliance with ISO 13485 by managing the Integrated Management System (IMS).
7. Collaborate with management on business improvement initiatives within time and budget constraints.
8. Conduct supplier and internal audits.
9. Serve as the regulatory contact for U.S. product and material requirements and as the FDA registration representative.
10. Stay updated on industry developments by reviewing technical publications and abstracts.
11. Report and analyze quality issues periodically and present findings.
12. Participate in professional associations related to quality and regulation.
13. Update and improve business processes continuously.
14. Lead and support continuous improvement initiatives using DMAIC, Lean, 5S, Six Sigma, and other tools.
15. Assist process owners in updating the IMS.
16. Act as a key user for SAP Enable Now (SEN) and 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.
• Public speaking and presentation skills.
• 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, regardless of race, color, religion, sex, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, political affiliation, military service, or other non-merit factors. This policy applies to all employment terms and conditions.