Regulatory Affairs Manager (Medical Devices)

The Regulatory Affairs Manager will play a fundamental role in maintaining continued regulatory compliance with standards and medical device regulations. The ideal candidate will join a dynamic team launching innovative technology.

Client Details

Our client is a cutting edge medical device manufacturer. They have multiple marketed products, as well as new products awaiting registration in UK, EU and ROW markets.

Description

• Coordinate and manage regulatory submissions and approvals in line with industry standards.
• Ensure compliance with applicable regulations and guidelines within the life sciences industry.
• Monitor regulatory changes and update internal processes as required.
• Provide strategic advice on regulatory matters to support business objectives.
• Develop and maintain relationships with regulatory authorities and key stakeholders.
• Prepare and review documentation to ensure accuracy and compliance.
• Collaborate with internal teams to align regulatory strategies with organisational goals.
• Support audits and inspections related to regulatory compliance.

Profile

• Proven record of working with Medical device regulations, and liaising with regulatory bodies.
• Good knowledge of QMS activities.

Job Offer

• Competitive salary
• 4 Day Working week
• Permanent position based in West London