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Regulatory Affairs Specialist

Apply now Job no: 615435
Work type: Permanent
Location: Gothenburg
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 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 are growing and have an excellent opportunity to join our Regulatory Pipeline team as a Regulatory Affairs Specialist based in Mölnlycke, Sweden, reporting to a Regulatory Affairs Director, also based in Mölnlycke.  

The Regulatory Pipeline 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. We succeed by collaborating with our local team for International Registrations and our regional Regulatory team across the globe 

In the pre-market phase, this role leads, or supports another member of the Pipeline team, to provide advice to our development project teams on regulatory requirements. This to ensure the product is ready to submit for our key markets, e.g. EU, USA/Canada, China, Japan and Australia, according to timeline.  

In the sustaining phase the role provides regulatory support to the sustaining engineering and manufacturing groups, specifically by assessing product and process changes and delivering regulatory advice on required activities as well as executing applicable regulatory filing.   

With a continuously changing regulatory landscape this role can become involved in impact analysis of new and/or updates standards and regulations, as well as working on improving our processes and workways. 

You will be part of a collaborative team in a global context, reporting to a manager who is flexible, and supports development and growth. Ideally you have regulatory affairs experience, however we are open to consider candidates with equivalent capabilities, if we find that the profile fits our needs. 

In this role your key responsibilities will be:  

  • Act as, or support, the primary liaison between our regional teams and the project team for regulatory and standard compliance advice, issue resolution and technical support through product development 

  • Support, or when appointed, take responsibility and accountability of the development of the regulatory strategy to support business plans for both product development, sustaining and retirement projects 

  • Define technical documentation needs and ensure that they are delivered to quality and timeline requirements by collaborating with e.g., R&D, Clinical, Marketing, Manufacturing 

  • Prepare the EU-submission process to gain new or modified products approval  

  • Support our regional teams as well as the International Registration Team with adapting or creating technical dossiers appropriate for regional market submissions and license renewals 

  • Conduct assessments to identify regulatory filing requirements for proposed or planned product, labelling and manufacturing changes, and deliver required documentations (e.g. Letter to Files)  

  • Review regulated labelling and promotional material for regulatory impact before release 

  • Perform impact analysis of new/updated standards and regulations, and participate in improving QMS processes  

 

Bring your skills and experience 

  • Ideally 3+ years of experience in Regulatory Affairs, or equivalent capabilities, that demonstrates 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 

  • Deep understanding of business processes and how they interact with Regulatory processes 

  • Technical expertise and experience in the design and development and manufacturing of regulated products 

  • Demonstrated interpersonal, communication and relationship building skills, enabling you to manage stakeholders at all levels within the business, build and leverage relationships and work collaboratively in cross-functional teams 

  • Ability to analyse and clearly convey complex information to peers, supervisors and other stakeholders 

  • Commercial acumen with the ability to make judgements and provide advice which balances the business interest and regulatory risk. 

  • 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 team mates 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 

At Cochlear, we’re committed to providing support for a lifetime of hearing. That’s how we deliver on our mission. While our global headquarters are located in Sydney, Australia, here in Sweden we have a site in Mölnlycke that’s home to a range of global functions that design, develop, manufacture, market and support our world leading bone conduction and cochlear implant solutions. 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. The site is just 10 minutes from Gothenburg’s city centre and at the site we employ approximately 220 people whose responsibilities include research, product design and development, marketing, quality, regulatory, supply, people & culture and administration. 

#cochlearcareers #TogetherCochlear

Advertised: W. Europe Standard Time
Anticipated Application Closing: W. Europe Standard Time

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