Regulatory Affairs Assistant| J&J MedTech

Position:
Regulatory Affairs Assistant – Med Tech

Location:

Leeds, West Yorkshire, United Kingdom

The Regulatory Affairs Assistant will help support New Product Development, Life Cycle Management, and product registration activities across the Depuy Synthes Portfolio. Responsibilities include assisting with CE marking, UK CA mark, and USA FDA submissions, and working on project plans in accordance with regulatory and company requirements.

• Provide full support to all registration activities, including CE marking and US FDA submissions.
• Facilitate worldwide product registration by compiling appropriate dossiers, submissions, and responses to regulatory bodies.
• Maintain processes for submissions, interim notifications, change notifications, and periodic re‑submissions.
• Maintain information on worldwide regulatory requirements and the status of product registrations.
• Liaise with all departments and project teams to coordinate timely applications for CE marking and other approvals.
• Provide support and advice to product development and other colleagues concerning global regulatory requirements.
• Support maintenance of regulatory metrics and databases, including preparation of associated reports.
• Support compliance and audit activities during planning, preparation and response phases.
• Stay aware of progress and developments of worldwide regulatory requirements.
• Communicate business‑related issues or opportunities to the next management level.
• Perform additional duties as assigned.

• Regulatory experience related to medical devices.
• Knowledge of worldwide regulatory procedures, especially for medical devices.
• Experience working in worldwide markets with a proven track record of on‑time project completion.
• Computer competency in Microsoft Office, data collection and general analysis tools.
• Excellent planning, organisational, and communication skills.
• Product awareness and thorough knowledge of regulatory frameworks.
• Cross‑cultural awareness, team player, enthusiastic, and committed.

You will receive a competitive compensation and benefits package that can be tailored to your needs throughout different stages of your life.

Johnson & Johnson is an equal opportunity employer and is committed to providing an inclusive work environment where all employees are respected, and diversity and dignity are honored.