EU Regulatory Lead - Medical Devices & Combinations

IRL - 1380 Takeda Pharmaceuticals Intl AG Ireland Branch; Dublin; On-site; EUR 117,000 - 161,000; Full time

Job summary

Takeda Ireland seeks an experienced Regulatory Affairs professional to act as the PRRC RA for EU medical devices under the MDR framework. You will manage liaisons with Notified Bodies and authorities, ensure up-to-date documentation, and drive regulatory strategy and submissions across the EU and EEA.

The role requires leadership, cross-functional collaboration, and strong communication skills to support launches and lifecycle management of device products in the European market.

Qualifications

• Experience with EU MDR 2017/745 and regulatory requirements for medical devices.
• Notified Bodies and health authority interactions experience.

Responsibilities

• Lead PRRC RA activities for EU Authorised Representative.
• Ensure Declaration of Conformity and technical documentation are up-to-date.
• Prepare and submit documentation to Notified Body for devices and combination products.
• Monitor regulatory changes in the EEA and update requirements.

Skills

Regulatory expertise

Stakeholder influence

Regulatory strategy

Documentation review

Communications (written/oral)

Education

BS/BA in a Scientific Discipline

Job description

Takeda Ireland seeks an experienced Regulatory Affairs professional to act as the PRRC RA for EU medical devices under the MDR framework. You will manage liaisons with Notified Bodies and authorities, ensure up-to-date documentation, and drive regulatory strategy and submissions across the EU and EEA.

The role requires leadership, cross-functional collaboration, and strong communication skills to support launches and lifecycle management of device products in the European market.