Senior Regulatory Affairs Specialist
Job no: 608473
Work type: Permanent
Categories: Quality & Regulatory, Western Europe, Individual Contributor
Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As the 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.
This is a fantastic opportunity for an experienced Senior Regulatory Affairs Specialist to work in our Cochlear Bone Anchored Solutions in Mölnlycke, Sweden in our Regulatory Department and reporting directly to the Regulatory Affairs Manager. This is a newly created position as we expand our Regulatory team. You will be tasked as the primary liaison between the regions and the project teams for regulatory inquiries, issue resolution and technical support. The opportunity is provided to contribute and innovate processes and documentations to influence change within Cochlear.
The purpose of the Senior Regulatory Affairs Specialist role is to provide regulatory support throughout the lifecycle of Cochlear products. In order to be successful candidate for this role you will need an awareness of how to develop innovative solutions to streamline product portfolio registration systems and processes.
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
- Performance of labelling reviews and approval before publication
- Address European regulatory requirements by vigilance reporting
- 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 compliance and regulatory issues
The successful candidate will have the unique opportunity to shape Cochlear’s BAS business. Cochlear BAS is the division of Cochlear that designs and manufactures the world’s leading bone conduction and other implantable acoustic solutions. 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.
- Degree in Scientific, Engineering, or Healthcare; or experience in regulatory affairs in medical device industry
- A strong capacity and willingness in interpersonal 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
- 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 that can be used to prepare submissions to regulatory authorities such as FDA, EU and in country regulators
- Commitment to a hands on approach to support establishment of team processes and procedure
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, bone conduction implant and active middle-ear implant systems.
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 applying online today.
Advertised: W. Europe Daylight Time
Applications close: W. Europe Daylight Time
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