XB Consultants: Regulatory Affairs Manager
Regulatory Affairs Manager
Position: Regulatory Affairs Manager – Medical Devices
Location: Zurich, Switzerland
Overview:
Our client, a specialist Medical Device company with a global presence is seeking an ambitious Regulatory Affairs professional to join their team in Zurich focusing on regulatory activities across all product groups – the market coverage is both Switzerland wide and global!
This is an outstanding opportunity for a professional RA to join an expanding medical device company and develop your career while playing a key role in the continued advancement of this International group!
Responsibilities Include:
· Responsible for developing regulatory pathways for Medical Device products and projected costs for the budget
· Strategic and tactical input in development, post approval and life cycle management
· Prepare and maintain regulatory submissions – both Switzerland and International
· Support the Marketing organisation and other commercial teams as well as close liaison with global R&D
· Coordinate with vendors and Quality on preparation of new regulatory requirements, guidelines and procedures
· Responsible for keeping abreast of emerging legislation and highlight any potential impact on the relevant product / market / business
· Establish and maintain relationships with regulatory bodies / agencies
· Manage submission tracking and document control activities
· Publish submissions in relevant electronic format as required
Candidate Profile:
· Educated to degree level ideally within a scientific area or RA/QA background
· At least 3-4 years’ experience as a Regulatory Affairs Associate / Manager
· Proven track record of preparing and publishing regulatory submission documents
· Demonstrable knowledge of Regulatory Affairs preferably with strong knowledge of ISO 9001 & 13485
· Experience in multiple products, multiple phases of development
· Experience working with regulatory bodies / agencies and regulatory procedures across Switzerland and European / global experience an advantage
· Project management skills
· Fluent English and German language skills
· Excellent communicator
Social
Switzerland / Zürich / Genf / Bern / Basel
