Jr. Regulatory Executive (Maven)

Roles and Responsibilities

Key Responsibilities:

• Develop, review, and maintain regulatory documentation in accordance with EU MDR 2017/745, including technical documentation, risk management files, and clinical evaluation reports.

• Conduct gap assessments against EU MDR requirements to identify areas for improvement and support implementation strategies.

• Coordinate with cross-functional teams to gather data and ensure alignment of regulatory submissions with product design and development processes.

• Stay updated on relevant regulatory testing requirements and ensure compliance with applicable standards.

• Support the preparation of Notified Body submissions, responses to queries, and audit readiness.

• Interpret global regulatory requirements and translate them into clear guidance and actionable plans for internal and client teams.

Qualifications & Skills:

• Bachelor’s or Master’s degree in life sciences, biomedical engineering, pharmacy, or a related field.

• Minimum 6 months of hands-on experience in regulatory affairs within the medical device industry.

• Demonstrated expertise in EU MDR 2017/745, with experience preparing clinical, risk, and performance documentation.

• Strong understanding of ISO 14971 and MEDDEV guidance.

• Excellent communication, documentation, and project management skills.

• Ability to work independently, prioritise tasks, and manage deadlines across multiple projects.