Overview:

This is a 100% onsite role based in Westbrook, ME, with a focus on supporting the IVDR (In Vitro Diagnostic Regulation) business. The role involves managing international projects, collaborating with various departments, and ensuring the smooth transfer of products across countries. The project manager will work cross-functionally with teams in the U.S., Japan, and China, and will play a key role in supporting regulatory, quality, and business process improvements.

Key Responsibilities:

• Manage interactions between internal teams and third-party manufacturers (TPMs).
• Coordinate and oversee international projects.
• Collaborate on IVDR changes across departments.
• Support business process improvements and project delivery.
• Ensure timely completion of multiple projects, identifying and resolving issues to prevent delays.
• Lead meetings and set clear goals and deadlines.
• Ensure design and regulatory compliance.
• Apply Soft Process Failure Mode Analysis (PFMEA) to drive quality improvements.

Required Skills and Experience:

• Project Management: Must be a self-starter with 3+ years of project management experience.
• Regulatory Knowledge: At least 1 year of experience in a regulated environment, working with regulatory bodies, or within regulatory departments.
• Software Proficiency: Strong skills in Microsoft Office Suite (Excel, PowerPoint, Power BI, Project) and the ability to create charts and timelines.
• Cross-Functional Collaboration: Experience working with quality and regulatory teams, including technical regulatory collaboration.
• Industry Experience: Familiarity with the medical device, pharmaceutical, or healthcare industry, specifically in project transfers and regulatory contexts.

Education:

• Minimum Associate's degree in Project Management or related field, or equivalent combination of education and experience.

Additional Information:

• Must be flexible to attend occasional evening meetings (8:30/9:30 EST) with international teams (Japan, China).
• Local candidates preferred; relocation is at the candidate's expense.
• This is a 100% onsite role, with no remote work option.