Job Purpose:<\/p>\n
\tResponsible for ensuring that Genop Healthcare maintains high standards of compliance in accordance with the current ISO 13485 Standard for Medical Devices, as well as all Pharmaceutical and Cosmetics GxP Standards and other legal requirements<\/p>\n
Reporting to:<\/p>\n
\tResponsible Pharmacist<\/p>\n
Key Job Outputs:<\/p>\n
\tAssisting in the submission and final registration and\/or listing of new Medical Devices with the SAHPRA, for the long-term growth and benefit of the Genop business.
\n\tAssist in the maintenance and update of all dossiers, Medical Device files and listings and any other applicable licenses (e.g. Radiation Control) for all Genop products in South Africa.
\n\tAssist to ensure that all Regulatory activities performed are following all the relevant provisions of the Medicines and Related Substances Act 101 of 1965, and any other countries’ legislation where applicable.
\n\tUnderstand and interpret government legislation and industry codes of practice relating to Regulatory Affairs, QA and Product Surveillance in South Africa.
\n\tProviding any requested Regulatory documents or available Literature for Genop products to Port Health or Customs when requested, to ensure no delays in stock being made available for sale.
\n\tApproval of advertising and promotional materials to ensure compliance with the SA Code of Marketing Practise and any other applicable legislation and internal guidelines.
\n\tApproval of company events, meetings, grants, sponsorships and donations in line with the SA Code of Marketing Practise.
\n\tAssist with the approval of all local artwork for Genop products to ensure compliance from a Regulatory, Quality and Compliance perspective.
\n\tAssist in continuously improving the Genop Quality Management System (QMS) in line with the ISO 13485 Standard, and any other applicable GxP standards.
\n\tAssist in the release of products (Cosmetics and Medical Devices) as per the Final Product Release SOP to ensure that only high-quality products are released for sale into the market and support the Supply Chain team to ensure the timely release of quality products into the market.
\n\tAssist in co-ordinating product Recall activities when required, in collaboration with Regulatory Affairs, the Adcock DC\u2019s and the Supply Chain team.
\n\tAssist in ensuring that retention\/release samples are received, checked, stored and recorded for all relevant product batches released to market.
\n\tEnsure that some QA and other relevant quality related SOPs are put in place and updated as per the renewal schedule, Co-ordinate some deviations as per the approved processes.
\n\tAssist in the implementation of the required corrective and preventative actions (CAPA) and ensure that all QA or technical related matters are solved in a timely manner.
\n\tEnsure that an effective Post Marketing Product Surveillance System is in place for Genop that is compliant with ISO 13485 & SAHPRA’s requirements, and external Supplier\u2019s requirements and any other applicable Genop standards and procedures.
\n\tEnsure that all reports of Adverse Events (AEs) received are logged and submitted to the relevant heath authorities, institutions and to the global suppliers as applicable.
\n\tManage and record all Product Quality Complaints (PQCs) or queries and customer returns, with the relevant stakeholders.
\n\tPQCs and AEs are to be trended to identify recurring issues or ineffective CAPA’s.
\n\tRequest and file all Post Market Clinical Follow-up (PMCF) reports from the suppliers for any identified high risk Medical Devices.
\n\tEnsure that all local AE and PQC trackers are always current and up to date.
\n\tEnsure timely response and regular follow-up for any PQC or AE reports and queries.
\n\tEnsure that the Genop \u201cProduct Quality Complaints\u201d and the \u201cPost-Marketing Vigilance\u201d SOPs are in place and kept current and updated as per their renewal schedule.
\n\tEnsure full understanding and implementation of the SAHPRA Guideline on Adverse Event and Post-marketing Vigilance Reporting for Medical Devices.
\n\tDrive staff awareness of the ISO 13485 Standard and the specific requirements thereof as it relates to Medical Devices sold by Genop.
\n\tEnsure that all medical queries received are actioned or referred to the appropriate person and responded to on time.<\/p>\n
Core Competencies:<\/p>\n
\tProfessional verbal and written communication skills.
\n\tAbility to prioritise and work to tight deadlines.
\n\tProblem solving and decision-making skills.
\n\tAttention to detail.
\n\tAbility to act with integrity when working with highly sensitive and confidential matters.
\n\tHighest level of ethics, integrity and commitment<\/p>\n
Job Requirements<\/p>\n
\tRelevant Scientific or Pharmaceutical Science Degree or Diploma.\u00a0
\n\tAt least 5 years\u2019 experience in the Pharmaceutical or Medical Device Industry in a Product Surveillance or RA\/QA Officer position.
\n\tMedical Device and ISO 13485 experience is a distinct advantage
\n\tExperience in Product Surveillance and SA Marketing Code Compliance.<\/p>\n
Closing Date: 27 October 2025<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( N \/ A ) or<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"","_company_name":"Adcock Ingram","_company_website":"http:\/\/N%20\/%20A","_company_tagline":"Adcock Ingram is a leading South African pharmaceutical company with a proud 130 year heritage. It has a portfolio of trusted, quality brands and generics and an entrenched value system that assures integrity. Growing from humble beginnings as a small Krugersdorp pharmacy in 1890, Adcock\u2019s portfo... read morelio includes an extensive range of Prescription, Over-the-counter (OTC), Consumer and Hospital products and life saving hospital products.","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[12],"class_list":["post-22071","job_listing","type-job_listing","status-expired","hentry","job_listing_region-gauteng","job-type-full-time"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/22071","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=22071"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=22071"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=22071"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}