Regulatory Affairs Specialist

Cochlear is the global market leader in implant hearing solutions. 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. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.

Regulatory Affairs Specialist EMEA- Remote

About Us: At Cochlear, our mission is to help people hear and be heard. As a global leader in implantable hearing solutions, we are proud to improve the lives of millions worldwide. Every day, we empower individuals by connecting them with sound and ensuring they have access to advanced hearing technology. At the heart of our work is a commitment to innovation, collaboration, and creating solutions that truly matter. By joining our team, you’ll be a part of an ASX-listed multinational organization that embraces diversity, fosters growth, and offers a unique opportunity to make a meaningful impact.

About the Role:
This position is specifically focused on supporting our operations within the EMEA (Europe, Middle East, and Africa) region. It is not a head office or manufacturing-based role but is integral to ensuring regulatory compliance and effective collaboration across our regional offices and distributors. You’ll work remotely while engaging closely with regional stakeholders, regulatory authorities, and cross-functional teams. The geographical scope of the role spans multiple countries, providing a unique opportunity to work in a diverse and culturally rich environment.

Your Profile:
We’re looking for a highly motivated Regulatory Affairs Specialist with a passion for excellence and a knack for detail. Whether you’re an experienced professional or seeking to elevate your career, you’ll thrive here if you are:

• Educated: Hold a Bachelor’s or Master’s degree in a relevant field (e.g., biomedical sciences).
• Experienced: Have 1-2 years of experience in regulatory affairs, particularly with medical devices or pharmaceuticals.
• Knowledgeable: Familiar with regulatory databases (e.g., EUDAMED, MHRA) and global compliance principles.
• Linguistic Skills: Proficiency in English is a must for this role. Knowledge of an additional EMEA language is a strong plus.
• Tech-Savvy: Skilled in Microsoft Office and, ideally, software like Confluence, Jira, or SAP.
• Organized: Possess excellent multitasking, attention to detail, and problem-solving abilities.
• Communicative: Able to build relationships across cultures and teams with strong written and verbal communication skills.

Bonus Skills:
• Expertise in ISO 13485 and quality management systems.
• Interest or experience in project management.
 

Your Responsibilities:
As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance, supporting strategic initiatives, and facilitating smooth regulatory processes across the EMEA region. Your contributions will include:

• Regulatory Operations:
• Preparing and filing local regulatory registrations and submissions.
• Maintaining regulatory databases (e.g., EUDAMED, DMIDS) and ensuring records are up-to-date.
• Monitoring changes in local regulations and assessing their impact.
• Collaboration:
• Acting as a liaison between regulatory authorities, regional offices, and internal teams.
• Supporting operations, marketing, and quality teams with regulatory compliance needs.
• Reviewing marketing materials to ensure compliance with approved claims.
• Innovation & Improvement:
• Supporting projects to streamline registration systems and processes.
• Contributing to developing procedures and best practices within EMEA Regulatory Affairs.
• Stakeholder Engagement:
• Cultivating relationships with regulatory authorities and in-country representatives.
• Acting as the Service Desk for regulatory support requests from internal stakeholders.

Your Benefits:
At Cochlear, we recognize and reward talent with a comprehensive package, including:

• Remote Work: Enjoy the autonomy and balance of working from home while connecting with a dynamic, international team.
• Career Growth: Opportunity to develop expertise in regulatory affairs, cross-functional collaboration, and project management within a globally recognized organization.
• Meaningful Impact: Work on innovative projects that help people reconnect with the sounds of life.
• Global Exposure: Be part of a multicultural team, engaging with stakeholders across EMEA.
• Learning Opportunities: Gain experience in cutting-edge technologies, quality management systems, and regulatory databases.
• A competitive salary and benefits package, reflecting your expertise and contribution.

Why Join Cochlear?
Here at Cochlear, we don’t just work; we innovate, collaborate, and make a difference. Join us to be part of a culture that values diversity, continuous learning, and meaningful contributions. Together, we’ll shape the future of hearing solutions and change lives across the globe.

Ready to join our mission?
Apply now and start your journey with Cochlear today! 

Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.

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.

#CochlearCareers

How we recognise your contribution

We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.

For more information about Life at Cochlear, visit www.cochlearcareers.com

At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you.