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