Senior/Principal Regulatory Affairs Specialist

Summary about this job

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

• Based at our Iconic HQ Building Macquarie University
• Market leading medical devices business
• Flexible company benefits tailored to suit your needs

Cochlear is the global market leader in implant hearing solutions and is a top 100 company on the ASX. 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.

We have an opportunity to join our highly regarded Regulatory team as a Principal Regulatory Affairs Specialist.

The purpose of the role is to provide regulatory support, guidance and expertise by developing global regulatory strategies and identifying what data is required for our business.  You will be the lead regulatory representative on assigned product or project teams.  Its crucial that you can define, organise and perform all necessary regulatory tasks to guarantee that the business/marketing strategy is delivered on time. As well as these tasks you will also provide guidance regarding regulatory-related issues throughout the entire product range and product lifecycle, in accordance with business needs. Your understanding of worldwide Regulations will help you to actively participate in global projects

You will bring:

Minimum:

• Advanced Degree in relevant field (sciences, biomedical), RACS certification preferred.
• Minimum 7 years of professional experience in Regulatory Affairs, with demonstrated knowledge/experience in the following areas:
• Broad understanding of medical device regulations associated with the product development and approval process.
• Proven track record of management, compilation, submission and maintenance of regulatory filings.
• Managing Regulatory Affairs tasks for the preparation, implementation and execution of submissions within designated timeframes, including timely responses to Agency questions.
• Manage the interactions with Regulatory Agencies and external providers in order to meet designated timeframes and maintain regulatory compliance.
• Deep understanding of business processes and how they interact with Regulatory processes (product design and development, verification, validation, realization, distribution, quality, clinical trials, etc…)
• Creativity, foresight and ability to provide input and impact analysis to activities of importance.
• Demonstrated interpersonal and project management skills; able to deal with pressure from many stakeholders; able to work under tight deadlines.
• Strong attention to detail and organizational skills as demonstrated by the ability to complete work on time, with minimal errors.
• Strong verbal and written communication skills.
• Demonstrated analytical thinking skills to identify and resolve problems.
• Proven experience working with cross functional teams in a commercial environment.

Ideal:

• Previous pharmaceutical or medical device regulatory experience preferred
• Knowledge of the new European Medical Device Regulation
• Experience executing global regulatory strategies
• Established network with regulatory agencies.

Development Value of this role:

• Opportunity to work across organization boundaries, manufacturer, regional offices, understanding of a very broad selection of operations of the company.
• Engage with extensive internal and external stakeholders, exposure to working in a cross cultural and multi-lingual environment.
• Visibility to regional business planning and forecasting processes.
• Develop innovative solutions to streamline product portfolio registration systems and processes.

Take the first step towards a career with Cochlear. A career you can be proud of. Apply online today