Regulatory Strategy Lead – Medical Devices & QA

Cambridge Consultants; Cambridge; On-site; GBP 45,000 - 65,000; Full time

Job summary

A global technology consulting firm based in Cambridge is seeking a Regulatory Affairs Specialist. The role involves providing regulatory support across various teams, ensuring compliance with international regulations, and leading initiatives to optimize quality management systems. Ideal candidates will have a track record in regulatory strategy development, strong leadership skills, and knowledge of medical device compliance. This position offers a dynamic environment to innovate and influence across industries.

Qualifications

• Experience in compliance with quality standards ISO 9001:2015, ISO 13485:2016.
• Proven track record in developing regulatory strategies.
• Knowledge of medical device compliance requirements.

Responsibilities

• Provide company-wide regulatory support across projects.
• Identify and monitor changes in relevant international regulations.
• Lead communications on quality and regulatory updates.
• Support fulfilment of external audit requirements.
• Facilitate team efforts with strong leadership skills.

Skills

Compliance with product regulations

Regulatory strategy development

Leadership in project management

Attention to detail

Job description

A global technology consulting firm based in Cambridge is seeking a Regulatory Affairs Specialist. The role involves providing regulatory support across various teams, ensuring compliance with international regulations, and leading initiatives to optimize quality management systems. Ideal candidates will have a track record in regulatory strategy development, strong leadership skills, and knowledge of medical device compliance. This position offers a dynamic environment to innovate and influence across industries.