Project Manager R&D, Compliance

Medline•Northfield, MN

8d•Hybrid

About The Position

The Compliance Project Manager is a hands-on role responsible for executing and driving completion of critical quality and regulatory initiatives. This role is accountable for day-to-day program execution, ensuring tasks are clearly defined, owned, communicated, tracked, and completed on time with appropriate documentation to support regulatory compliance.

Requirements

Bachelor's degree in Engineering or Science related field.
At least 2 years of experience in a medical device or pharmaceutical related field.
Project Management
Microsoft Project or Smartsheet
Knowledge of medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
Position may require travel up to 10% of the time for business purposes (domestic and international).

Nice To Haves

PMP Certification
Experience with regulatory agency communications
Experience with audits/inspections
Strong working knowledge of QMS elements, CAPA processes, and FDA/ISO requirements.
Highly organized with strong attention to detail and follow-through.
Ability to drive execution and hold action owners accountable in a fast-paced environment.
Strong communication skills with ability to work across all levels of the organization.
Proficiency with tracking and reporting tools (e.g., Smartsheet, Excel dashboards)
Working familiarity with data structures and concepts (e.g., data lakes, data pipelines, or enterprise data environments)
Exposure to supporting implementation or updates of software systems

Responsibilities

Manage all aspects of internal projects regarding ongoing compliance of medical devices, dietary supplements, cosmetics, and/or OTC/ANDA/NDA drugs.
Leading collaborative, multifunctional teams consisting of stakeholders of various levels across R&D, quality, regulatory, manufacturing, and product divisions.
Driving cross-functional quality and regulatory compliance initiatives, including FDA 483 response programs, CAPA remediation efforts, and internal process improvement projects.
Serve as a central coordinator to ensure timely, compliant, and traceable execution of commitments with strong alignment to regulatory requirements and business objectives.
Maintain team engagement by ensuring timely and transparent communication.
Lead process improvement initiatives.