The VP or SVP of Regulatory Affairs & Quality Management is responsible for all regulatory and quality activities for the Company’s North American operations importing, manufacturing and distributing Class I and II durable medical equipment and respiratory products. Maintains oversight of the Company’s global Quality Management System, and ensures compliance with all applicable regulatory standards. Manages the RA/QA team, including director and senior director-level heads of Regulatory Affairs, Quality Assurance, Quality Control and Purchasing Control. Reviews and maintains existing systems, and creates and implements new systems where required. Transitions all sites, including corporate headquarters, acquired properties, domestic and international manufacturing sites and distribution centers, to the Company’s global QMS. Fosters a culture of compliance awareness and teamwork.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Continually evaluates and maintains the existing Quality Management System, and creates and implements new policies and procedures where required.
Builds excellent working relationships across departments to maintain a culture of compliance awareness, cooperation and solution-oriented focus.
Maintains thorough and current knowledge of all applicable domestic and international regulatory standards.
Serves as the point of contact for the FDA and comparable international regulatory agencies, successfully manages regulatory audits and facility inspections, and devises and implements plans to effectively and efficiently remediate any adverse findings.
Oversees all quality assurance activities, including document control, drafting and validation.
Oversees all domestic and international quality control activities, including inspections in Asia and all US distribution centers.
Oversees all regulatory, trade compliance, and foreign registration requirements, including state licensing and labeling.
Oversees all purchasing control activities, including management of internal and external audits of Asian and other international suppliers to ensure good manufacturing practices and ethical sourcing.
Travel required (approximately 30%) to US locations and properties, as well as Asia.
EXPERIENCE/QUALIFICATIONS, KNOWLEDGE, AND SKILLS:
Strong working knowledge of 21 CFR 820, ISO 13485, EU Medical Device regulations, CE Mark registration and other domestic and international regulatory standards as applied to Class I and II devices.
Extensive experience with quality controls in China, including familiarity with GMP and ES standards as applied by both regulatory bodies and retail customers; ability to travel to Asian manufacturing sites when necessary.
Ability to facilitate interaction and cooperation between compliance and other departments to avoid risk and maintain alignment of goals.
Ability to directly interact with government compliance officers and investigators in a cooperative and productive manner.
Ability to develop and maintain excellent interpersonal relationships and proactively manage a large, cross-functional team of personnel in several different locations.
Working knowledge of MasterControl.
Bachelor’s degree in Engineering, Science, Quality, or Manufacturing Leadership
Drive DeVilbiss is one of the fastest growing durable medical equipment businesses that markets and distributes its products to customers located throughout North America, Europe, Central America, South America, the Middle East and Asia. Drive carries a complete line of durable medical equipment including mobility products, beds, bariatric products, wheelchairs, sleep surfaces and pressure prevent...ion products, respiratory equipment, self-assist products, power wheelchairs, power scooters, rehabilitation products, pediatric products, patient room equipment, personal care products and electrotherapy devices.
Seventeen years after its inception, Drive DeVilbiss is recognized as one of the most innovative and fastest growing companies in its industry through a focus on quality, value and customer service. Privately held, the company anticipates continuing its historical growth record to achieve $1 billion in revenues in the near term through both aggressive organic and acquisition expansion.