Senior Regulatory Affairs Associate

Summary about this job

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

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

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.

We are recruiting for a Senior Regulatory Affairs Associate, APAC in our Regulatory Affairs team within the CMO office. The Senior Regulatory Affairs Associate plays a critical role in preparation of regulatory submissions, license renewals and registrations within the Asia Pacific (APAC) region, including Australia. There is opportunity to contribute and innovate processes and documentation to influence change within Cochlear.

Key Responsibilities

The purpose of the Senior Regulatory Affairs Associate, APAC position is to work closely with employees from all functional areas to ensure clear, concise and accurate documentation is submitted to regional partners and regulators. In order to be a successful candidate for this role you will need to demonstrate active involvement in the implementation and improvement of systems and process methods to improve deliverables.

In this role you will be responsible for:

• regulatory strategy and planning by ensuring regulatory and business plan submissions are submitted within agreed timelines and according to local regulatory requirements
• the compilation, submission, approval and maintenance of regulatory files while ensuring a system functions effectively to monitor, track and communicate regulatory status
• the provision of cross-functional regulatory direction by supporting compliance of clinical studies, advertising material, labelling and publicly disseminated information with relevant laws & regulations

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 a relevant Science or Engineering related discipline,
• Proven experience in regulatory affairs in medical device or other therapeutic goods industry
• A strong capacity for interpersonal collaboration and project management skills; able to deal with pressure from many stakeholders; able to work under tight deadlines.
• Ability to make judgements and process advice which balances the business interest and regulatory risk while managing stakeholders at all levels within the business
• Strong attention to detail and organisational skills as demonstrated by the ability to complete work on time, with minimal errors and minimal supervision.
• Broad understanding of medical device regulations associated with the product development and approval process
• Excellent intelligence of business processes and how they interact with regulatory processes
• Strong written and verbal English communication skills
• Excellent capacity to work with cross functional teams in a commercial environment

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.