Senior Regulatory Affairs Specialist

Summary about this job

Detail information about job Senior Regulatory Affairs Specialist. Terms and conditions vacancy

• Based in Cochlear's iconic Sydney headquarters
• Highly visible and cross functional role, ability to influence broadly
• Project Management focus, multiple innovative projects

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 the 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.

This is a fantastic opportunity for an experienced Senior Regulatory Affairs Specialist to work in our Regulatory Department at our Cochlear Global HQ. You will work closely with our project teams developing documentation and executing regulatory strategies to support our regional colleagues as we seek approval for our innovative products around the world.

Key Responsibilities

The purpose of the Senior Regulatory Affairs Specialist role is to provide regulatory support throughout the lifecycle of Cochlear products. In order to be a successful candidate for this role you will need an awareness of regulatory authorities such as the FDA and TGA, EU Notified Bodies.

In this role you will be responsible for:

• Regulatory strategy and planning by supporting project teams with Regulatory compliance advice through product development and be pro-active in communicating potential impact of regulatory activities on marketing plans
• Regulatory submission and related activities by preparing and managing the submission process to gain new or modified products approval and maintain product licenses for current product portfolio
• Provision of cross-functional regulatory direction provided by being a champion for regulatory requirements and guidelines, contributing technical knowledge, and provide analysis and guidance on pre- and post-market compliance issues

The successful candidate will have the unique opportunity to shape Cochlear’s flagship business. You will have the benefit of working across multiple interesting and innovative projects, with significant career development avenues for the right person. Cochlear offers a supportive and collaborative working environment with ample opportunity to progress.

Key Requirements

• A Bachelor’s degree in Science, Engineering, or Healthcare; or experience in software or product development, quality and/or regulatory affairs
• The capacity and willingness to build relationships within a matrix team environment
• Ability to make judgements and process advice which balances the business interest and regulatory risk while managing stakeholders at all levels within the business
• Sound understanding of medical device standards and regulations
• Strong written and verbal communication skills that can be used to prepare submissions to regulatory authorities such as FDA, EU Notified Bodies and a range of in country regulator
• Commitment to a hands on approach to support establishment of team processes and procedures

Cochlear Summary

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™).

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.