Job Details

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.

At McKesson Medical Surgical we work with health systems, physician offices, extended care providers, in-home patients, labs, payers and other providers in non-acute care to supply them with medical-surgical, lab and Rx products and technology solutions to run their businesses so they can take care of patients.

Position Summary:

The Sr Associate, Regulatory Monitoring will support regulatory compliance activities for McKesson Brands, with a primary focus on reviewing and ensuring labelling compliance for private label medical products. This role will also provide operational and administrative support to the Regulatory Monitoring Specialist and contribute to the continuous improvement of regulatory processes.

Key Responsibilities:

Labelling Compliance Review

• Review product labelling for McKesson Brands to ensure compliance with applicable regulatory requirements (e.g., FDA, ISO standards).
• Maintain and update labelling documentation and records.
• Collaborate with cross-functional teams (e.g., Product Development, Quality, Marketing) to ensure timely and accurate labelling updates.
  

Regulatory Monitoring Support

• Assist the Regulatory Monitoring Specialist in tracking and interpreting regulatory changes relevant to McKesson Brands.
• Support the implementation of regulatory updates into internal procedures and documentation.
• Help prepare documentation for internal audits and regulatory inspections.
  

Documentation and Reporting

• Maintain regulatory files and databases to ensure audit readiness.
• Assist in the preparation of regulatory reports and summaries.
• Support the development and revision of SOPs related to labelling and regulatory monitoring.
  

Cross-functional Collaboration

• Liaise with internal stakeholders to gather information and ensure alignment on regulatory requirements.
• Participate in team meetings and contribute to regulatory strategy discussions.

Experience Required:

• Minimum 2+ years of experience in regulatory affairs, preferably in the medical device or healthcare industry.
• Experience with labelling review and regulatory documentation preferred.
• Familiarity with FDA regulations (21 CFR), ISO 13485, and EU MDR is an advantage.

Education:

• Bachelor’s degree in a scientific, engineering, or regulatory discipline or equivalent experience.

Specialized Knowledge/Skills:

• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple tasks and deadlines in a fast-paced environment.
• High learning aptitude and adaptability with software systems.

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 supportphysical, 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