Regulatory Affairs Specialist International Registrations

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.
We have an excellent opportunity for a regulatory affairs professional to join our International Registration team as a Regulatory Affairs Specialist based in our site in Mölnlycke, Sweden.
The International Registration team leads Cochlear’s efforts to obtain and maintain global regulatory approvals and licenses that allow us to deliver the outstanding products we develop and manufacture to our customers.
In this role, you will be responsible for the international registration regulatory submissions and post-approval commitments, to enable efficient delivery of documentation and information and to support market expansion. You will coordinate the assessment of regulatory intelligence forms submitted by the regions on behalf of the legal manufacturer, analysing the potential impact on the business and proposing implementation plan options with input from cross functional business partners.
You will be part of a collaborative team in a global context, reporting to a manager who is flexible, and supports development and growth.
Key Responsibilities
In this role you will be responsible for:
International Registration fulfilment of requests for documentation and information for registration purposes across all regions, focussing on submissions outside of the USA, EU and Australia
Assessing the impact of changes to International regulatory requirements notified by the regional regulatory teams through the Regulatory Intelligence Process, assisting with assessments with cross-functional teams
Providing guidance on regulatory issues, and support process improvement initiatives.



Bring your skills and experience
Advanced degree in relevant field (Science, Biomedical)
Minimum of 3 years of professional experience in software or product development, quality and/or regulatory affairs Broad understanding of medical device regulations associated with the product development and approval process
Demonstrated interpersonal, communication and relationship building skills, enabling you to manage stakeholders at all levels within the business
Experience in project management, where you have been accountable for delivering results within defined timeframes
Able to make judgements and provide advice which balances the business interest and regulatory risk.
Be motivated by achieving goals and meeting timelines in a fast-paced and highly technical environment, where you can feel proud that the work you do helps more people around the world to hear again and live full lives.
You are comfortable speaking and writing in English at a professional level (Swedish is ideal but not essential)
You will enjoy spacious, modern facilities, surrounded by a beautiful forest in Mölnlycke
You will experience an engaged workplace, motivated teammates and a supportive manager
You are looking for a company which has a focus on wellness for its employees
You are looking for that next career move where you can utilize your skills but also challenge yourself to learn something new



A Little Bit 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™).
#cochlearcareers #TogetherCochlear
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