Senior Specialist Regulatory Affairs

SHL Group AB QA & RA Department, Nacka Strand - Tillsvidare - Heltid

Would you like to develop long term as part of a growth company, which continuously strengthens its position through innovative products? Then this is the position for you!

SHL Group AB, part of SHL Medical, offers you a position in a dynamic environment where we develop and manufacture products that improve people’s health and quality of life. As an employee you take a great responsibility and join a global organization at an expanding stage. We are now seeking a Senior Specialist Regulatory Affairs for our office in Nacka Strand, Stockholm.

As a Senior Specialist within Regulatory Affairs, you will be part of a team of 3 highly skilled people and you will work closely together with the Quality Assurance team. Main focus will be to contribute to and support various development projects, throughout the product life cycle. This means interacting with most functions and departments at SHL Group AB, such as Development, Project Management, Innovation, Business Development and so on. You will also be in contact with and provide support to customers and their RA representatives, as well as internally with our SHL colleagues in Taiwan, US and Switzerland.

As a Senior Specialist Regulatory Affairs, you carry out various work tasks, for example:

  • Act as company liaison with regulatory health authorities. Develop regulatory strategic plans specific to development programs.
  • Lead and author delivery of regulatory submission dossiers. Drive and implement process and system improvements to ensure successful submission outcomes.
  • Ensure applicable regulations and standards are integrated within the organization by e.g. participate in standardization organizations.
  • Guide the organization including management teams to ensure that SHL complies with up-to-date regulations and standards pertaining medical device and other products or services.
  • Management of SHL's certificates, authorizations, device registration etc. 
  • Provide input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submission and approval.
  • Acting as coordinator and/or single contact point < SHL-Customer/Authority > in submission process.
  • Directly involved in the preparation, assembly and submission of all global regulatory documents, such as MAF, CTD and other international regulatory submissions in various countries.
We see that you have a background within QARA, and that you have a MsC or corresponding work experience. You are fluent in English, in speech and writing. We highly value experience within the medical device field and/or experience from working with pharmaceutical companies. You have strong communication skills and have the will and ability to work and collaborate in a global company.

Would you like to know more? Please visit our website or follow us on LinkedIn. 
We welcome your application!

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      Om arbetsgivaren

      Established in 1989, SHL Group (Scandinavian Health Limited) is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems such as auto injectors. With several distinct group companies, our product line ranges from injectors to pressure mattress systems, to laboratory handling equipment to neurosurgical devices.

      SHL Medical designs and manufactures advanced products for drug injection and is the world’s leading supplier of auto injectors. With headquarters in Switzerland and sites in Sweden, the US and Taiwan, SHL Medical partners with the world's largest pharmaceutical and biotechnology companies to provide the world with innovative, life changing medications. SHL Medical employs more than 5 000 worldwide, with around 120 employees at our design office SHL Group AB in Nacka Strand.