Regional Device & Drug Delivery Center Director

PCI Pharma Services; Stamullen; On-site; EUR 120,000 - 180,000; Full time

Job summary

PCI Pharma Services seeks a senior leader in device development, responsible for translating customer needs into strategic device solutions, with extensive regulatory experience across FDA and EU pathways.

You will drive risk management, design controls, and scale-up programs, partnering with Regulatory Affairs, QA, and external OEMs to deliver timely, compliant submissions and product launches.

Qualifications

• Bachelor's degree in Mechanical, Electronic, Biomedical, or Manufacturing Engineering (advanced degree preferred).
• 10+ years' experience in combination product / drug delivery device development, with at least 3 years in a senior leadership role.
• Demonstrated expertise in autoinjector, pen injector, or needle safety device design, assembly, and industrialization.
• Strong working knowledge of ISO 11608, ISO 11040, ISO 14971 and the Metrology equipment to meet it, ISTA/ASTM transport standards, and design controls (DHF/DMR).
• Experience supporting 510(k) submissions and combination product regulatory pathways (FDA, EU MDR/CTR as applicable).
• Track record of building or leading a technical center, lab, or center of excellence supporting external pharmaceutical clients.
• Hands-on familiarity with root-cause investigation tools (CT scan, X-ray, high-speed imaging) and automation/tooling program management.
• Strong client-facing communication skills; comfortable operating at both technical depth and executive summary level.

Responsibilities

• Translate UN into a defined container closure and device strategy aligned to dosing and patient population.
• Own Label & Packaging design activities, including DFM of packaging and linkage with the Design Lab.
• Direct device assembly and test process design from concept samples through DV samples.
• Define and deploy scale-appropriate automation strategy for clinical vs. commercial scale.
• Establish assembly in-process control and inspection concepts to ensure build quality.
• Embed and maintain ISO 14971 risk management across the full product life cycle.
• Provide regulatory leadership for 510(k) and combination product submissions with Regulatory Affairs and QA.
• Lead cross-functional device RCA investigations and translate findings into robust control plans.
• Represent the RTC in client-facing technical discussions, proposal development, and governance.

Skills

Leadership

Regulatory strategy

Autoinjector design

ISO standards

510(k) submissions

Client-facing

Product launches

Timeline discipline

Education

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

Tools

CT scan

High-speed imaging

X-ray equipment

Metrology equipment

Job description

PCI Pharma Services seeks a senior leader in device development, responsible for translating customer needs into strategic device solutions, with extensive regulatory experience across FDA and EU pathways.

You will drive risk management, design controls, and scale-up programs, partnering with Regulatory Affairs, QA, and external OEMs to deliver timely, compliant submissions and product launches.