Quality/Regulatory Specialist

McKesson; United States; Remote; USD 59,000 - 99,000; Full time

Job summary

A leading healthcare company is seeking a Quality and Regulatory Specialist to ensure compliance with regulatory requirements for private label products. The role involves reviewing documentation, handling customer complaints, and supporting quality processes. Candidates should have a Bachelor’s degree in science or engineering and a minimum of 4 years’ experience in the Pharmaceutical or Medical Device industry. Competitive compensation and benefits are offered.

Benefits

Comprehensive benefits package

Competitive compensation

Qualifications

• Minimum 4 years’ experience in Quality Assurance and/or Regulatory Affairs within the Medical Device or Pharmaceutical industry.
• Familiarity with FDA regulations, ISO 13485:2016, ISO 14971, and ISO 10993 series.

Responsibilities

• Review and maintain product qualification documents for compliance.
• Receive, assess, and process product complaints from customers.
• Support continuous improvement of quality and regulatory processes.

Skills

Strong written and oral communication skills

Technical writing proficiency

Analytical and problem-solving skills

Attention to detail

Education

Bachelor’s degree in science or engineering

Tools

MS Office (Word, Excel, SharePoint, PowerPoint)

Job description

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – 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.

Key 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.

Experience Required

• Minimum 4 years’ experience in Quality Assurance and/or Regulatory Affairs within the Medical Device or Pharmaceutical industry.
• 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 aligned with organizational priorities.
• 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.

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position

€49,800 - €83,000