Interim Regulatory Specialist at Cochlear

About Bravura:

Vi på Bravura jobbar med bemanning och rekrytering. Hos oss finns möjligheter för dig som vill ta nästa steg i karriären. Välkommen att hitta ditt drömjobb genom oss – som konsult eller rekryterad.

About the job:

This is a full-time consulting assignment that lasts for 6-8 months. There is a possibility for extending the assignment. You will either be employed by Bravura as a consultant, or if you have your own company and F-tax certificate, you can be employed as a subcontractor.

About the company:

Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear, including cochlear implant systems and bone conduction solutions. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded implant system than any other. Their employees tell them 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 them as they tackle complex challenges to fulfil their mission to help people hear and be heard.

Cochlear operates all over the world, with global offices primarily based in Australia and Sweden. At the Cochlear Gothenburg Site there are approximately 250 employees whose responsibilities include research, product design and development, marketing, quality and regulatory, manufacturing, distribution and administration.

Tasks and responsibilities:

As a Senior Regulatory Affairs Specialist, you are the key to ensuring that Cochlear's products comply with regulations throughout their lifecycle. You will be a central advisor during both the pre- and post-market phases of their products. In the pre-market phase, you will collaborate with cross-functional project teams in research and development to ensure their products meet regulatory requirements. Your role involves assessing DHF-documentation to ensure it is submission-ready. In the post-market phase, you will instead provide support to teams in sustainable technology development and manufacturing. This includes assessing changes both in the product and the process and providing guidance on necessary verification and validation (V&V) as well as other required documentation. Additionally, you may be responsible for submissions to regulatory authorities, such as the FDA, EU notified bodies, and national regulators. As the primary point of contact for regulatory matters, you will be the link between Cochlear's regional and regulatory teams and project teams. This involves handling issues, providing technical support, and ensuring compliance with regulations. Your role also includes representing Cochlear's interests and practices regarding regional regulations such as CEL, CAM, CLA, and CAP. This includes participating in company discussions and being a voice for Cochlear on regulatory matters.

Education, Experience and Personal characteristics:

• Bachelor's degree in engineering, regulatory, natural sciences, or healthcare
• Minimum of 3 years' experience in quality and/or regulatory affairs in global markets within Medtech, experience in higher risk classes is desirable
• Fluent in English, both spoken and written
• Proficient computer- and system skills in PLM systems

To succeed in the assignment, we see that you are a structured person who plans your tasks carefully, always setting and adhering to deadlines, and knowing what to prioritize. You pay attention to detail and carry out your work thoroughly to ensure that everything is done with quality and accuracy. In this role, you have several internal and external collaboration areas which you enjoy, and with your communication skills, you're not afraid to communicate decisions and inform about regulatory requirements to be followed. To thrive in Cochlear's culture, we see that you enjoy a dynamic work environment where you are open to changes and are flexible in decision-making processes and work methods.

Other information:

Start: Upon agreement
Location: Mölnlycke, Gothenburg
Salary: Upon agreement

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