Senior Regulatory Affairs Specialist

5 hours ago


Johannesburg, Gauteng, South Africa Kinetic Business Solutions Full time R900 000 - R1 200 000 per year

Kinetic
is working with a leading
Medical Device
company who are hiring a
Senior Quality Assurance & Regulatory Affairs Specialist
to be based in
Johannesburg
.

This is a 6-month maternity cover position.

***Please take the time to read the job description, you must meet all the criteria set out below for your application to be considered. We do check all applications and suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion.***

Key aspects of the role include:

  • Facilitates all related technical information and applicable documentation for licensing of products.
  • Collaborate with cross-functional teams to address regulatory issues and ensure compliance with regulatory standards, regulations, and guidelines.
  • Coordinate internal quality audits.
  • Assist in developing a plan and implementation of a Quality Management System.
  • Work closely with the Quality Management team for all Quality-related matters including complaints procedures.
  • Provide support to the sales team and supply chain management for tenders and customer requests.
  • Lead or support RAQA projects and assignments as required.

To be successful you will need to meet the following:

  • Bachelor's Degree in Pharmacy.
  • Minimum of 4 – 6 years of regulatory affairs experience.
  • Good Knowledge of QA and RA requirements, compliance regulations and industry practices.
  • Motivated, proactive, dynamic, methodical, organised, and decisive.
  • Applicants should be available for face-to-face interviews in the location mentioned above.

Hiring? If you need help filling a similar position in your company, please contact us on or
click here
.

***We check all applications and suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion.***



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