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Medical - Manufacturing & Distribution Jobs

Regulatory Affairs & Quality Assurance Specialist

Job Information
LocationRecruitment Agency / Vacancy in South Africa. Johannesburg
SalaryR750k- R550k
Job TypePermanent
EducationB.Pharm and registered with SAPC
Experience5-10 years

Job Description

As a Regulatory Affairs and Quality Assurance Specialist you will be primarily responsible for the integration and upkeep of the site Total Quality Management System including all National and Corporate policies and procedures in accordance with ISO13485. The role will include ensuring company compliance with sound QA and RA principles and related to all medical devices in SADC including GMP, SOP’s, audits, training and customer complaints.


• As a Regulatory Affairs and Quality Assurance Specialist you should have a knowledge of ISO13485 implementation and upkeep

• Previous experience in Quality Assurance and/or Regulatory Affairs

• Fluency in English language

Other skills:

• Excellent communication skills

• Self-motivated

• Good time management skills

• Able to work under pressure

• Flexible

• Route cause analysis


• As a Regulatory Affairs and Quality Assurance Specialist you will be responsible for the upkeep of Compliance to RA and QA systems

• ISO and other RA or QA systems implementation and upkeep

• Audits internal and external (conduct and assist)

• On-going QA and RA review and monitoring of compliance against established key performance indicators

• Follow-up and report back on post market surveillance activities entered into the relevant systems for processing;

Should you meet the requirements for this position, please email your CV to or fax to 086 571 7307 or alternatively call on 021 551 8638.

Correspondence will only be conducted with short listed candidates. Should you not hear from us within 3 days, please consider your application unsuccessful.

Hire Resolve offers a R1000 for any candidate that I referred and placed through Hire Resolve. Hire Resolve also offers a R1000 job spec fee for any referral that results in a placement through Hire Resolve. If your company is looking for any IT, Finance and Engineering staff, please email us at with the company name, a contact person and contact email or number of the person doing the hiring. We will keep the referral strictly confidential.

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