Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Baxter International

Kista, Sweden

Summary

Join us on our journey to save and sustain lives in the role as a Regulatory Affairs Specialist covering the Nordics, focusing on Sweden (based close to our office in Kista). In this role you will work with both medical devices and pharma products. You will ensure marketing authorizations and maintenance for pharmaceuticals and medical devices, manage local RA activities for the Nordic countries, support business product launches and tender application. You will work closely with our Global RA team and have an opportunity to participate in different projects to develop our RA working model within RA Western Europe.

Essential Duties and Responsibilities

  • Nordic RA Specialist for new and marketed products, pharma and Medical devices;
  • Nordic RA responsibility on assigned Business Unit portfolio;
  • To assure regulatory compliance on applied, approved and/or marketed medicinal products and medical devices in Nordic countries;
  • Understand EU regulations for both pharmaceuticals and medical devices (MDR);
  • National Competent Authorities (NCA) communication in Sweden and other Nordic countries;
  • Work closely with other Nordic and Global RA Leads for new submissions, variations, renewals, withdrawals and deficiency letters for medicinal products;
  • Maintain internal and external product information databases and change controls;
  • Initiate, review and approve Labeling Change Requests;
  • Review and approve marketing material together with medical and business teams.

Qualifications

  • Based in Sweden with good experience of working with Swedish Medicines agency (or other Nordic medicines agency), knowledge about requirements for pharma products and/or medical devices;
  • Good relationships with Läkemedelsverket;
  • Degree in Pharmacy, Chemistry, Life science or similar;
  • Minimum 2-5 years’ experience within the health care and/or MedTech industry, preferably within Regulatory Affairs;
  • Communicate fluently in Swedish and English internally and externally.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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