Executive Director, Regional Device & Drug Delivery Center

PCI TRGR Penn Pharmaceutical Services Ltd; Ireland; Remote; EUR 150,000 - 230,000; Full time

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd, Stamullen, Co. Meath, IRL, invites a Director to lead the Regional Device & Drug Delivery Center of Excellence.

You will drive strategy for autoinjector and needle safety devices, oversee packaging design, and ensure right-sized automation across clinical and commercial programs. You will embed ISO 14971 risk management, lead regulatory interactions including 510(k) submissions, and provide technical leadership across R&D, QA, Regulatory Affairs and

Qualifications

• 10+ years in combination product / drug delivery device development.
• 3+ years in a senior leadership role.
• Experience with autoinjector, pen injector, or needle safety devices.
• Experience with ISO 11608, ISO 11040, ISO 14971 and related metrology.
• Experience supporting 510(k) submissions and regulatory pathways.
• Track record in leading technical centers or centres of excellence.

Responsibilities

• Lead translation of UN into a defined device strategy and packaging concepts.
• Own Label & Packaging design activities and DF M alignment with Design Lab.
• Direct device assembly and test process design from concept to DV samples.
• Define automation strategy aligned to program volume and maturity.
• Establish in-process control and metrology concepts for lot release data.
• Drive Right First Time validation and ISO 14971 risk management across life cycle.
• Provide regulatory strategy leadership for 510(k) and regulatory submissions.
• Lead cross-functional RCA investigations and translate findings into control plans.
• Represent RTC in client discussions, proposals, and governance meetings.

Skills

Mechanical Engineering

Electronic Engineering

Biomedical Engineering

Manufacturing Engineering

Autoinjector design

Leadership

Root-cause analysis

Education

Bachelor’s degree in Mechanical/Electronic/Biomedical/Manufacturing Engineering

Advanced degree preferred

Tools

CT scan

X-ray imaging

High-speed imaging

Metrology equipment

Job description

PCI TRGR Penn Pharmaceutical Services Ltd, Stamullen, Co. Meath, IRL, invites a Director to lead the Regional Device & Drug Delivery Center of Excellence.

You will drive strategy for autoinjector and needle safety devices, oversee packaging design, and ensure right-sized automation across clinical and commercial programs. You will embed ISO 14971 risk management, lead regulatory interactions including 510(k) submissions, and provide technical leadership across R&D, QA, Regulatory Affairs and