Program Manager - Mdr

Job Title: Engineering Project Manager III

Location: Remote

Duration: 12 months

JOB SUMMARY:

Program Manager of the MDR Remediation Program that covers multiple projects/submissions across the four portfolios within Front Line Care. Responsible for managing overall execution and communication between the individual remediation teams, key stakeholders, and leadership.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Coordinates work performed within multiple functions including R&D, Packaging, Operations, Regulatory and Quality by facilitating project scope definition, managing budget, and monitoring risk on a program level scale.

• Supports MDR team by assessing and managing resource allocation, progress tracking and facilitating budget and schedule changes through the change control process.

• Ensures adherence to quality standards and reviews project deliverables with stakeholders.

• Manages vendor partners, provides guidance to project team, provides senior leadership withstatus updates.

•Strong partner with Regulatory leadership and Certificate Strategy team to ensure successful certifications for all in scope products.

UNIQUE QUALIFICATIONS AND SKILLS:

• Good communication and organizational skills required.

• Must have previous experience as a project manager in medical device field for a minimum of 5 yrs.

• Experience with EU regulatory systems and requirements as well as technical knowledge of operations execution

• PMI Certification preferred.

• Excellent analytical and pragmatic problem-solving skills.

• Ability to provide strategic advice as well as operational solutions

• Strong interpersonal skills with the ability to influence and communicate with individuals at all levels in an organization

• Proven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectives

• Track record in providing high degree of reliance, accountability, and value-added consultation/support to business managers and other support functions

EDUCATION AND EXPERIENCE:

Bachelor’s Degree or local equivalent of same; generally, 8-11 years of experience (minimum 5).