Regulatory Affairs

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**Job Purpose**:
Responsible 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

**Reporting to**:
Responsible Pharmacist

**Key Job Outputs**:
Assisting 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.

Assist 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.

Assist 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.

Understand and interpret government legislation and industry codes of practice relating to Regulatory Affairs, QA and Product Surveillance in South Africa.

Providing 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.

Approval of advertising and promotional materials to ensure compliance with the SA Code of Marketing Practise and any other applicable legislation and internal guidelines.

Approval of company events, meetings, grants, sponsorships and donations in line with the SA Code of Marketing Practise.

Assist with the approval of all local artwork for Genop products to ensure compliance from a Regulatory, Quality and Compliance perspective.

Assist in continuously improving the Genop Quality Management System (QMS) in line with the ISO 13485 Standard, and any other applicable GxP standards.

Assist 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.

Assist in co-ordinating product Recall activities when required, in collaboration with Regulatory Affairs, the Adcock DC’s and the Supply Chain team.

Assist in ensuring that retention/release samples are received, checked, stored and recorded for all relevant product batches released to market.

Ensure 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.

Assist 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.

Ensure 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’s requirements and any other applicable Genop standards and procedures.

Ensure 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.

Manage and record all Product Quality Complaints (PQCs) or queries and customer returns, with the relevant stakeholders.

PQCs and AEs are to be trended to identify recurring issues or ineffective CAPA's.

Request and file all Post Market Clinical Follow-up (PMCF) reports from the suppliers for any identified high risk Medical Devices.

Ensure that all local AE and PQC trackers are always current and up to date.

Ensure timely response and regular follow-up for any PQC or AE reports and queries.

Ensure that the Genop “Product Quality Complaints” and the “Post-Marketing Vigilance” SOPs are in place and kept current and updated as per their renewal schedule.

Ensure full understanding and implementation of the SAHPRA Guideline on Adverse Event and Post-marketing Vigilance Reporting for Medical Devices.

Drive staff awareness of the ISO 13485 Standard and the specific requirements thereof as it relates to Medical Devices sold by Genop.
- Ensure that all medical queries received are actioned or referred to the appropriate person and responded to on time.

**Core Competencies**:

- Professional verbal and written communication skills.
- Ability to prioritise and work to tight deadlines.
- Problem solving and decision-making skills.
- Attention to detail.
- Ability to act with integrity when working with