Overview
McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We deliver insights, products, and services that make quality care more accessible and affordable. We focus on the health, happiness, and well-being of our people and those we serve, and we care.
What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.
Position Summary
Reporting to the Director of Quality, the Quality and Regulatory Specialist is responsible for reviewing product qualification documentation to ensure compliance for McKesson private label products and customer-branded products across international markets. This role supports regulatory alignment, documentation accuracy, and complaint handling.
Responsibilities
* Product Qualification & Documentation Review: Review and maintain product qualification documents for private label products distributed internationally. Ensure documentation aligns with applicable U.S. FDA regulations (excluding submission responsibilities) and other international regulatory requirements. Coordinate with suppliers and contract manufacturers to obtain and verify technical documentation, declarations of conformity, and product specifications. Maintain organized records of product approvals and compliance evidence for internal and customer use.
* Customer Complaint Handling: Receive, assess, and process product complaints from international customers. Request additional information to fully understand reported events. Evaluate complaints for potential regulatory impact and escalate as needed. Support timely and accurate reporting in accordance with applicable international regulations.
* General QA/RA Support: Maintain working knowledge of U.S. FDA regulations and international standards relevant to medical devices, cosmetics, and dietary supplements. Support continuous improvement of quality and regulatory processes, including updates to SOPs and QMS documentation. Participate in internal and external audits as required.
* Additional Responsibilities: The above statements describe the general nature and level of work being performed. Additional responsibilities may be assigned as required.
Qualifications
* Experience: Minimum 4 years’ experience in Quality Assurance and/or Regulatory Affairs within the Medical Device or Pharmaceutical industry.
* Regulatory knowledge: Familiarity with FDA regulations, ISO 13485:2016, ISO 14971, and ISO 10993 series. Knowledge of regulations for cosmetics and dietary supplements is a plus.
* Education: Bachelor’s degree in science or engineering.
* Specialized Knowledge/Skills: Strong written and oral communication skills; technical writing proficiency; high learning aptitude and adaptability with software systems; project management capabilities; ability to work effectively in dynamic environments; strong analytical and problem-solving skills; customer-focused mindset; excellent attention to detail and planning ability; cultural awareness and sensitivity.
* PC/Equipment: Proficient in MS Office (Word, Excel, SharePoint, PowerPoint).
Work Environment/Physical Demands
* General office environment.
* Limited travel, both regional and international, may be required.
Compensation & Benefits
As part of Total Rewards, McKesson offers a competitive compensation package determined by factors including performance, experience, skills, equity, market evaluations, and geographical markets. The base pay range for this position is €49,800 - €83,000. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities, may be offered.
#J-18808-Ljbffr