Regulatory Affairs Assistant J&J MedTech

Position

Regulatory Affairs Assistant

Location

Leeds, West Yorkshire, United Kingdom

Job Summary

The Regulatory Affairs Assistant will help support New Product Development, Life Cycle Management, and product registration activities across the Depuy Synthes Portfolio. Help support CE marking, UK CA mark and USA FDA submissions to project plans in accordance with Regulatory and Company requirements.

Duties & Responsibilities

• Provide full support to all registration activities, CE marking and US FDA submissions.
• Facilitate worldwide product registration activities 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 company colleagues, particularly product development, concerning global regulatory requirements.
• Provide support to maintenance of regulatory metrics and databases. Preparation of associated reports.
• Support compliance and audit activities during planning, preparation and response phases.
• Be aware of progress and developments of worldwide regulatory requirements.
• Responsible for communicating business-related issues or opportunities to next management level.
• Perform other duties assigned as needed.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

Experience

• Regulatory experience covering medical devices.
• Knowledge of worldwide regulatory procedures, especially for medical devices.
• Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements.
• Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
• Possess computer competency in Microsoft Office software, data collection and general analysis tools.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

• Excellent planning and organisational, communication skills.
• Product awareness and thorough knowledge of respective regulatory frameworks.
• Thorough and flexible.
• Cross culturally aware.
• Team player.
• Enthusiastic and committed.