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Strategic Program Manager

1 week ago

Limerick, Limerick, Ireland Pale Blue Dot Recruitment Full time

About the Role:

We are seeking a highly skilled Strategic Program Manager - Medical Industry to join our team at Pale Blue Dot Recruitment. As a seasoned professional, you will be responsible for managing cross-functional teams to deliver innovative healthcare solutions from concept through to regulatory approval and commercialization.

The ideal candidate will bring technical expertise, leadership, and a solid understanding of the medical device lifecycle, quality, and regulatory requirements. Key responsibilities include:

  • Program Management: Manage multiple complex programs across the full medical device development lifecycle—from ideation through design, testing, and regulatory approval—aligned with strategic business objectives
  • Cross-Functional Collaboration: Work closely with product development, engineering, quality assurance, regulatory affairs, and commercial teams to drive seamless program execution
  • Regulatory Compliance: Ensure all projects comply with global regulatory standards (FDA, CE, ISO)
  • Quality Assurance: Champion quality assurance processes to ensure products meet the highest industry standards, regulatory expectations, and patient needs
  • Team Leadership: Mentor and lead cross-functional teams, fostering collaboration, accountability, and high performance

Requirements:

  • Degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a related discipline
  • Minimum 5 years of experience in program or project management within the medical device industry or a related healthcare/biomedical field
  • Experience in hearing technology or auditory-related devices is highly desirable
  • PMP, PgMP, or equivalent project/program management certification
  • Familiarity with ISO 13485, FDA regulations, and other applicable standards is a strong advantage

Core Competencies:

  • Proven leadership skills with the ability to manage and align multidisciplinary teams
  • Deep understanding of medical device development, design control, validation, and regulatory compliance
  • Excellent verbal and written communication skills, able to bridge technical and non-technical stakeholders
  • Proficiency with project management tools (e.g., Microsoft Project, JIRA, or equivalent)