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

Belimed; South Dakota; 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 within the U.S. business unit. This role involves implementing quality policies, managing compliance with ISO 13485, and conducting audits. The successful candidate will collaborate with management to drive business improvements and ensure adherence to regulatory standards. With opportunities for international travel and a focus on continuous improvement initiatives, this position offers a dynamic environment for professionals passionate about enhancing patient safety and operational excellence. Join a team committed to quality and innovation in the medical industry.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with Company Match

Paid Time Off

Flexible Work-from-Home Options

Qualifications

• 4+ years of experience with regulators in the medical industry.
• 8+ years of process management experience, including training.
• 6+ years of experience with Quality Management Systems.

Responsibilities

• Implement and develop programs to support quality policy.
• Manage CAPA Management System and ensure compliance with ISO 13485.
• Conduct audits and represent the organization in FDA registration.

Skills

Quality Management Systems

ISO 13485

Public Speaking

Process Management

Training and Coaching

Communication Skills

MS Office Suite

Continuous Improvement

Education

Bachelor’s degree in Engineering or Business Administration

Tools

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, and have offices in 9 countries worldwide, 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 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 position 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 and develop programs and systems to support strategic goals, including conducting training on these 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 effectiveness of Corrective and Preventive Actions.
4. Support the operation of the CAPA Management System and handle Non-Conformance processes such as audit findings, complaints, investigations, and reportable incidents.
5. Track quality and regulatory training for all employees using standardized document control forms (QMS document control).
6. Ensure compliance of the U.S. business with ISO 13485 requirements by managing the Integrated Management System (IMS).
7. Collaborate with management to establish and achieve 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 (importer role).
11. Review technical publications to stay current with industry developments.
12. Analyze, evaluate, and report on Quality Issues periodically.
13. Participate in professional associations related to quality and regulatory affairs.
14. Update and improve 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 updating the IMS.
17. Act as key user for SAP Enable Now (SEN) and as Business Analyst for US Quality & Regulatory.

Qualifications

1. Bachelor’s degree in Engineering or Business Administration.
2. At least four years of experience working with regulators in the medical industry.
3. Minimum of eight years’ process management experience, including training and coaching.
4. At least six years’ experience with Quality Management Systems, including ISO 13485.
5. Public speaking and presentation skills.
6. Excellent English communication skills, verbal and written.
7. Proficiency in MS Office Suite.
8. Ability to travel quarterly to Charleston HQ and obtain a valid passport for international travel.

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

Belimed, Inc. is an equal opportunity employer, committed to diversity and inclusion in the workplace, prohibiting discrimination and harassment of any kind.