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

Belimed; Arizona; 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 in the U.S. This exciting role involves implementing quality policies, managing regulatory compliance, and leading continuous improvement initiatives. You'll work in a dynamic international environment, collaborating with talented professionals dedicated to enhancing patient safety and health. If you have a strong background in quality management systems and regulatory affairs, along with excellent communication skills, this opportunity offers a chance to make a significant impact in the medical industry while enjoying a comprehensive benefits package and flexible work options.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with Company Match

Paid Time Off

Flexible Work from Home Options

Qualifications

• Bachelor's degree in Engineering or Business Administration required.
• 8+ years of process management and quality system experience needed.

Responsibilities

• Manage quality control and regulatory affairs for the U.S. business unit.
• Conduct audits and ensure compliance with ISO 13485 standards.

Skills

Quality Management Systems

Public Speaking

Process Management

Regulatory Affairs

Analytical Skills

Training and Development

ISO 13485 Compliance

SAP Enable Now

Lean Tools

Six Sigma

Education

Bachelor’s degree in Engineering or Business Administration

Tools

MS Office Suite

CAPA Management System

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 look back on more than 50 years of history. We have offices in 9 countries worldwide and are represented in over 80 countries thanks to 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, all of whom have dedicated themselves to making a difference in 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 will require travel of approximately 30 days throughout the year. Locations include our South Carolina headquarters, as well as customer sites throughout the US territory and periodic visits to our sites in Europe.

How you will impact Belimed and our clients:

• Implement the worldwide Belimed Quality Policy and derive appropriate programs and systems to support strategic direction and conduct training on those systems.
• Analyze quality / regulatory information for current and prospective products and present findings to local management and global counterparts.
• Manage cases in the CAPA Management System regarding documentation quality, time deadlines, and efficacy of Corrective and Preventive Actions.
• Support the operation of the CAPA Management System and understand the meaning of Non-Conformance handling processes such as audit findings, non-conformance, complaints, investigations, and reportable incidents.
• Track quality / regulatory training of all employees via standardized document control forms (QMS document control).
• Ensure the U.S. business complies with the requirements of ISO 13485 by managing the Integrated Management System (IMS).
• Partner with management to formulate and establish business improvement activities / goals that are accomplished within prescribed time frames and cost parameters.
• Conduct supplier and internal audits.
• Act as the regulatory contact person for U.S. product and material-related requirements.
• Act as U.S. representative for FDA registration of the organization (importer role).
• Review technical publications, articles, and abstracts to stay abreast of technical developments in the industry.
• Analyze, evaluate, and present (monthly / quarterly / annually) reported and responsible Quality Issues status and history.
• Attend and actively participate in quality / regulatory professional associations.
• Update and improve business processes.
• Drive a continuous improvement culture within the US organization to include: Lead cross-functional Continuous Improvement events using DMAIC model, lead and train value stream mapping exercises to define processes, work with the site to implement or streamline / improve use of LEAN tools, 5S, Six SIGMA, etc.
• Support process owners in making recommendations for updating / improving the Integrated Management System (IMS).
• Act as key user for SAP Enable Now (SEN).
• Act as Business Analyst for Belimed US Quality & Regulatory.

What you need to succeed:

• Bachelor’s degree in an Engineering-related field or business administration.
• Minimum four years working with regulators in the medical industry.
• Minimum eight years of process management experience including training, development, and coaching.
• Minimum six years of experience with the use and implementation of Quality Management Systems.
• ISO 13485 Quality System experience.
• Public speaking and / or presentation experience.
• Excellent verbal and written skills in the English language.
• Experience in MS Office Suite.
• Ability to travel to the Charleston HQ on a quarterly basis.
• Able to obtain a valid passport for occasional international travel.

As a full-time team member, you will be eligible for our excellent benefits package to include medical, dental, vision, life and disability insurances, 401(k) with a company match, multiple paid time off programs, flexible work from home options, and more!

Belimed, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex (including pregnancy, gender identity or expression, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit based factors. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.