6 days ago on jobsucher.jobagent.ch

Regulatory Affairs Manager - Medical Devices

XB Consultants

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Regulatory Affairs Manager - Medical Devices



Position: Regulatory Affairs Manager - Medical Devices

Location: Basel, Switzerland


Our client, a specialist Medical Device company with a global presence is seeking an ambitious Regulatory Affairs professional to join their team in Basel focusing on regulatory activities across all product groups (including IVD''s) – 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


David Brown


Geneva +41 (0)22 595 4608

London +44 (0)20 7803 4331