Senior Regulatory Affairs expert (Medical devices)

Job Title: client's IT Compliance department near Brussels, Belgium, as a CSV Lead. In this strategic role, you will be responsible for developing validation strategies, supporting internal compliance leads, and overseeing project deliverables. Your focus will be on organising validation processes and ensuring compliance with regulatory standards. You will be required to be on-site at least 2 days per week.

Key Responsibilities:

• Define Validation Strategies: Develop and implement comprehensive validation strategies to ensure regulatory compliance.
• Support Writing SOPs: Assist in creating and updating Standard Operating Procedures (SOPs) to streamline validation processes.
• Participate in Project Meetings: Actively engage in project meetings to provide validation expertise and guidance.
• Monitor Compliance, KPIs, and Deviations: Track key performance indicators (KPIs), monitor compliance, and identify and manage deviations.
• Assist the Team with Project Support: Provide support and guidance to the team to ensure successful project execution.

Requirements:

• Experience: Minimum of 5 years (preferably 10+ years) of validation experience.
• Expertise: In-depth knowledge of validation processes, GAMP guidelines, and Agile validation methodology.
• Autonomy: Seniority and the ability to work independently.
• Language Skills: Fluent in English; proficiency in French is a plus.

Nice to Have:

• Team Leading Experience: Experience leading teams in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPVP), and Good Laboratory Practice (GLP) domains.

Additional Information:

• The focus of the role is on a lead level, not the SME level. The person will not be writing validation documents but developing strategy.
• Due to the urgency of hire, the client can consider EU nationals who are able to relocate to Belgium or anyone who has a valid work permit for Belgium.

This role offers a unique opportunity to leverage your validation expertise in a strategic capacity, contributing to the compliance and success of our client's IT projects. If you meet the qualifications and are excited about the prospect of working in a dynamic and collaborative environment, we encourage you to apply.