Senior Regulatory Specialist

Job Description:  

• Enviable Product Pipeline
• Great Working Environment
• Leading Blue Chip Multinational

We are currently seeking an experienced Senior Regulatory Affairs professional to join the Quality & Regulatory Affairs team at our client’s Melbourne based operations.

This is an exciting opportunity to join a leading multinational on the cutting edge of medical technologies development and provide high level regulatory support for existing products and pipeline developments.

Duties:

• In brief the successful applicant will be responsible for providing regulatory support to existing products within the portfolio
• Providing advice on the interpretation of regulatory legislation and licence conditions
• Preparing high quality regulatory submissions related to all aspects of product development
• Working across cross-functional team to ensure customer satisfaction and regulatory compliance for sales and promotional materials.

Requirements:

• B.Sc. plus min 5-10 years’ regulatory experience, at least 2-3 years within medical technologies and/or diagnostics.
• An accomplished professional with a track record of successful planning and preparation of regulatory submissions within medical technology environment.
• Comprehensive knowledge of ISO13485 requirements
• Excellent communication skills – highly articulate with ability to work with interdepartmental teams.

Remuneration:

Salary: $ Negotiable

Contract / Permanent opportunity

Don’t miss out. Apply now in confidence.