Global Field Action Quality Manager (Solventum)

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Manager, Global Field Action (Solventum)

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role
As the Global Field Action Manager, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Developing, implementing, owning, and improving procedures and processes related to medical device, drug, combo product, and unregulated product fields actions globally to ensure timely execution, regulatory compliance, and optimization for the business.
• Creating and leading the governance and accountability models to monitor activity and drive continuous improvement for the global Field Action process
• Engaging with the FDA and other regulatory agencies globally as required
• Ensuring the timely and compliant execution of the global Field Actions per the process (multi-functional/global coordination of subject matter experts and key stakeholders) including tracking of major deliverables, including proper documentation, status updates and tracking, responses to regulatory authorities, and any other actions required
• Act as the subject matter expert on behalf of the company for any internal and external audits, with full accountability for the results in this functional area

Your Skills and Expertise 
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s Degree or higher and seven (7) years of Quality experience in a regulated environment

AND

In addition to the above requirements, the following are also required:

• (2) years of responsibility for managing and tracking Field Action responses and updates to regulatory agencies, ensuring timely submissions
• Familiarity with standards, regulations, and competent authorities such as US 21 CFR 210, 211, and 820, ISO 13485, ISO 9001, EU MDR, IVDR, Health Canada, ANVISA, COFEPRIS, MHRA, TGA, NMPA, PMDA, etc.
• Experience owning and executing global processes, engaging with cross-functional and global subject matter experts and stakeholders and updates to the appropriate regulatory authorities.  This includes experience engaging with the FDA on Field Actions (including recalls)
• Ownership and responsibility for global governance, monitoring, and execution of the Global Field Action quality sub-system.

Additional qualifications that could help you succeed even further in this role include:

• Experience with international locations and businesses
• Engaging with global (outside of US) regulatory agencies, competent authorities, notified bodies.
• Experience managing without authority, highly organized and able to operate effectively to (sometimes tight) deadlines
• Interpersonal communication skills (written and verbal).
• Written communication skills with regulatory authorities globally (heavy focus on FDA)
• Technical writing skills specific to Field Action documentation

Work location:  Remote - United States

Travel: May incl