Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.
The Opportunity
Cochlear has an opportunity for a R-619890 Labelling Requirements Analyst based in our Goteborg, Sweden office. In this role, the successful R-619890 Labelling Requirements Analyst leads and coordinates the lifecycle of labelling requirements and involves close interaction with product development teams and global and regional regulatory and marketing functions.

Responsibilities include:

• Be familiar with all sources of medical device labelling requirements including global and regional medical device standards and regulations. Review these standards and regulations for specific labelling requirements.
• Review product requirements and derive specific labelling requirements.
• Create and maintain templates for requirements documents, protocols and reports that meet all essential regulatory needs.
• Participate and lead change and improvement initiatives with particular emphasis on the adoption or creation of best-in-class processes and tools to ensure compliance with relevant regulations and standards for labelling.
• Implement Cochlear’s quality system through complying with and helping to enforce standard policies and procedures.

What makes this opportunity unique?
The role requires awareness of a rapidly changing regulatory environment and proactive participation and leadership of key process improvement initiatives for Cochlear to consistently meet global and regional regulatory labelling requirements. This role provides the Opportunity to work within large, multi-disciplinary implantable medical device projects.
About You
To add value to Cochlear in this role, you’ll be able to demonstrate the following skills and experience:

Minimum:

• Experience in analysing and developing requirements in a product development environment
• Proven elicitation skills to capture accurate and actionable requirements for ambiguous and complex projects
• Strong influencing skills in a matrix work environment
• Experience delivering to tight timelines
• Ability to manage stakeholders across the business and lead cross-functional collaborations
• Strong business analysis skills
• Degree or higher qualification and/or equivalent experience, preferably in the technical, regulatory or medical field
• Experience in using requirement gathering tools and writing requirement specifications

Ideal:

• Experience working in highly regulated multi-national medical device environments
• Understands the specific needs for creating effective and compliant user documentation and labels
• Experience in conducting systematic verification of technical documentation

A Little About Cochlear
Cochlear’s mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).

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• Be familiar with all sources of medical device labelling requirements including global and regional medical device standards and regulations. Review these standards and regulations for specific labelling requirements.
• Review product requirements and derive specific labelling requirements.
• Create and maintain templates for requirements documents, protocols and reports that meet all essential regulatory needs.
• Participate and lead change and improvement initiatives with particular emphasis on the adoption or creation of best-in-class processes and tools to ensure compliance with relevant regulations and standards for labelling.
• Implement Cochlear’s quality system through complying with and helping to enforce standard policies and procedures