Remote EU MDR R&D Engineer — Medical Devices

Actalent; Centennial (CO); Hybrid; USD 115,000 - 130,000; Full time

Job summary

Actalent is seeking an R&D Engineer to lead EU MDR compliance activities in a Denver/Colorado hybrid setting. You will drive design, documentation, and regulatory strategy across R&D, Regulatory Affairs, QA, Clinical, and Manufacturing teams to deliver safe, compliant devices.

You will develop design controls, support risk management, and produce audit-ready documentation while collaborating with Notified Bodies and cross-functional teams.

Qualifications

• Bachelor's or Master's in Mechanical, Biomedical, Electrical, or related engineering field.
• Experience in medical device R&D and regulated products.
• Experience preparing EU MDR compliant technical documentation.

Responsibilities

• Lead remediation design activities for medical devices per EU MDR 2017/745.
• Conduct studies, testing, and evaluations to align with regulatory and quality systems.
• Develop and maintain Technical Documentation and Files for EU MDR Annex II/III.

Skills

EU MDR compliance

Regulatory strategy

Risk management

Technical writing

V&V testing

Cross-functional collaboration

Design controls

CAPA investigations

Education

Engineering degree

Tools

SolidWorks

Windchill PLM

Job description

Actalent is seeking an R&D Engineer to lead EU MDR compliance activities in a Denver/Colorado hybrid setting. You will drive design, documentation, and regulatory strategy across R&D, Regulatory Affairs, QA, Clinical, and Manufacturing teams to deliver safe, compliant devices.

You will develop design controls, support risk management, and produce audit-ready documentation while collaborating with Notified Bodies and cross-functional teams.