Regulatory Affairs Lead — MedTech (CE/MDR)

BD Mexico; Limerick; On-site; EUR 57,000 - 86,000; Full time

Job summary

BD in Limerick, Ireland is hiring a Regulatory Affairs Specialist to support new product development and CE marking from concept to commercialization, collaborating with R&D, Quality and Engineering. The RA role involves applying knowledge of MDR/MDD, preparing regulatory documents, and maintaining compliance across systems.

This position requires a university degree and offers an opportunity to work with cross-functional teams in a dynamic, global environment at the Limerick site.

Qualifications

• Proven regulatory affairs experience within the medical technology industry or equivalent.
• Experience with MDR preferred.
• Bachelor’s degree in a scientific or engineering discipline is required.
• Knowledge of the regulatory frameworks for medical devices (MDD/MDR) is beneficial.

Responsibilities

• Lead RA activities on New Product Development projects to support CE marking from concept to commercialization.
• Provide RA leadership on sustaining engineering changes to released products.
• Propose workable solutions for complex regulatory challenges and drive projects to completion.
• Maintain high levels of quality and regulatory compliance in technical document preparation and reviews.

Skills

Regulatory affairs

MDR experience

Bachelor's degree

Medical devices

Education

Bachelor's degree in scientific or engineering discipline

Job description

BD in Limerick, Ireland is hiring a Regulatory Affairs Specialist to support new product development and CE marking from concept to commercialization, collaborating with R&D, Quality and Engineering. The RA role involves applying knowledge of MDR/MDD, preparing regulatory documents, and maintaining compliance across systems.

This position requires a university degree and offers an opportunity to work with cross-functional teams in a dynamic, global environment at the Limerick site.