Project Manager I

Job Title: Project Manager I

Location: Westbrook, ME

Skills and Qualifications:

Technical Proficiency:

• Strong experience with Microsoft Suite, including Excel, PowerPoint, Power BI, and Microsoft Project.
• Ability to create and maintain project charts and timelines.

Project Scope:

• Support IVDR (In Vitro Diagnostic Regulation) initiatives.
• Manage projects involving the transfer of products internationally — both from the U.S. to other countries and vice versa.
• Work on new product transfers into the U.S. for manufacturing.

Regulatory & Quality Expertise:

• Demonstrated experience working with Regulatory and Quality departments.
• Prior collaboration on technical regulatory compliance and documentation.
• Familiarity with Soft Process Failure Mode Analysis (PFMEA).

Industry & Regulatory Experience:

• Minimum 1 year of experience in a regulated environment.
• Hands-on experience with regulatory bodies or internal regulatory teams.
• Experience working within Pharmaceutical DME systems in a healthcare setting.

Education & Experience:

• Minimum Education: Associate degree in Project Management (Bachelor’s preferred).
• Experience:
• 3 years of project management experience.
• At least 1 year of experience in regulatory environments.

Key Responsibilities:

• Collaborate with cross-functional departments to implement IVDR changes.
• Manage communication and coordination between internal teams and third-party manufacturers (TPMs).
• Oversee and coordinate international project efforts and timelines.
• Drive business process improvements across departments.
• Lead and facilitate effective meetings, setting clear expectations, goals, and timelines.
• Proactively identify and resolve issues to prevent project delays.
• Manage multiple simultaneous projects and ensure on-time delivery.
• Ensure all activities meet design, quality, and regulatory compliance standards.
• Utilize Process Failure Mode and Effects Analysis (PFMEA) to improve product quality.