Life Science Recruitment is hiring for a Regulatory Affairs Specialist to join our clients expanding Life Sciences division. This is a hybrid role, the successful candidates will be responsible for managing Quality Systems, Regulatory Compliance, and support Quality Engineering activities for our clients and work for a variety of products and technologies to ensure compliance with medical device standards and regulations, including: 21 CFR Part 820, ISO 13485, MDD, AIMD, MDR and CMDCAS.


Responsibilities:

• Be a Regulatory Affairs subject matter expert for our clients, providing guidance and expertise
• Support development, collation, and review of data for US FDA, EU MDD/MDR regulatory submissions to Notified Bodies for Class I to III design dossiers and tech files
• Work with various functional teams within client companies to ensure device compliance to appropriate regulatory requirements
• Keep up to date with new or revised medical device regulations and standards to ensure continuous compliance for client projects
• Assess changes to products and documents with respect to relevant regulatory requirements
• Communicate with regulatory authorities for clients
• Support CAPA investigations
• Support Complaint investigations and report adverse events to the relevant notified bodies
• Support regulatory gap analysis assessments
• Assist clients with preparation and activities for Notified body and Internal audits

• Graduate with Engineering or Science degree, or equivalent experience
• Qualified systems lead auditor and MDD/MDR compliance is preferred.
• Minimum 2 years’ experience in a regulatory affairs role in the pharmaceutical, healthcare or medical device sector essential.

• Excellent client-facing skills
• People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
• Team work and emotional intelligence
• Good self-management – continuous performance is both an objective and a mind-set
• Has an innovative approach – a bold thinker and doer, matching creativity with vigilance
• High value on openness and transparency
• Strong interpersonal and communications skills,and fluent in English, both in writing and speaking
• Good technical report writing skills