Regulatory Affairs Officer

Posted 22 October by Bluestream Recruitment
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Are you an experienced Regulatory Affairs professional with a background in pharmaceutical or medical products?

Would you like to be part of a growing, supportive team at a leading healthcare company?

As a Regulatory Affairs Officer you will be rewarded with a competitive salary and be responsible for:

  • Being key contact between company and relevant Regulatory Authorities / Contractors
  • Ensuring that products comply with the local regulations in each sales region
  • Leading discussions and negotiations with Regulatory Authorities for Marketing Authorisations & Medical Device Certification
  • Maintaining up-to-date knowledge relating to National and International legislation, guidelines, and customer practices
  • Project managing teams involved with the development of new products and markets
  • Participating in regulatory inspections
  • Work closely with the Commercial Team to support entry of products into new markets

To be considered for the Regulatory Affairs Officer role you will need to be to:

  • Be educated to degree level or equivalent in relevant subject
  • Have previous regulatory affairs experience within a pharmaceutical or medical device environment
  • Be familiar with ISO 13485 Quality Management Systems
  • Have excellent communication skills - both written and spoken
  • Have strong Project Management skills
  • Have strong research and investigation skills
  • Have an understanding of scientific matters including scientific terminology and ability to critically review and scientific report

Bluestream Recruitment is an Equal Opportunities Employer and operates as an Employment Agency for permanent recruitment and as an Employment Business for temporary / contract recruitment.

Required skills

  • Compliance Monitoring
  • Product Compliance
  • ISO 13485
  • medical products
  • pharmaceutical products

Reference: 41225623

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