Job Description
About the Role
The Regulatory Affairs Administrator role at OttoBauthentic is a critical support function that ensures the efficient functioning of our department and compliance with regulatory requirements. This position requires a highly organized and detail-oriented individual to provide administrative, operational, and regulatory support.
Key Responsibilities
- Assist with day-to-day operations and administrative tasks of the company.
- Control the flow of promotional materials and master documentation.
- Complete assigned sections of registration dossier for submission to SAHPRA.
- Prepare and type resolution templates.
- Order product samples for laboratory analysis.
- Monitor updates and changes on SAHPRA and related websites.
- Update and maintain departmental Smartsheet plans.
- Maintain current knowledge of SAHPRA requirements.
- Prepare expense requisitions for the Finance Department.
- Prepare documents for uploading to supplier sites; download and systematically store supplier documents on the server.
- Assist with Reception duties when required.
- Perform any additional administrative tasks assigned by management.
- Compile permit applications for submission to SAHPRA.
- Review master documentation (BMRs, BPRs, API and FP specifications, etc.) in compliance with GMP and ISO 13485 standards.
- Compile assigned sections of generic registration dossiers.
- Submit third-party Site Master Files to SAHPRA.
- Use DocuBridge to source working documents and prepare submissions for publishing.
- Manage and maintain activities on the SAHPRA RIMS Portal.
- Build and maintain effective communication channels with SAHPRA representatives to support positive stakeholder relationships.
- Establish and maintain contact with manufacturers to obtain information timeously.
- Compile and update SOPs as required by SAHPRA and ISO 13485, within agreed timeframes.
- Proofread and verify artwork to ensure compliance with approved dossier labelling and regulatory requirements.
Requirements
- Matric Certificate
Qualifications
(No qualifications mentioned in the original job description)
Salary & Benefits
(No salary or benefits information mentioned in the original job description)
How to Apply
Click the green “Go Apply” button below to apply directly online with the employer.
About Other Medical Jobs in Gauteng
In Gauteng, the general job market trend for Other Medical positions is typically driven by an increasing demand for healthcare services, particularly in urban areas. This growth is often attributed to a growing population and an aging demographic, leading to a surge in medical tourism and specialized care needs.
When it comes to salaries for Other Medical professionals in Gauteng, it’s essential to note that compensation can vary widely depending on factors such as experience, company size, and industry sector. Generally, salaries tend to be higher in larger organizations or those in high-demand sectors, but even within smaller companies, salaries can still be competitive. Typically, salaries range from R400 000 to R700 000 per annum, with more senior roles or those in specialized fields potentially falling outside of this range.
Common skills required for Other Medical positions in Gauteng often include a strong foundation in medical sciences, excellent communication and interpersonal skills, the ability to work effectively in a team environment, and proficiency in relevant software applications. Many professionals in this field also possess advanced degrees or certifications, which can enhance job prospects and career advancement opportunities. Additionally, the ability to remain calm under pressure, think critically, and make sound judgments is essential for success in this role.
In terms of industry sectors, Other Medical professionals are often employed in financial services, technology industries, manufacturing sectors, and healthcare organizations. These sectors frequently require specialized care or expertise, making them attractive employers for medical professionals. While specific companies may not always be publicly disclosed as major recruiters, larger multinational corporations like Google and Microsoft often have a presence in these industries.
Career development opportunities for Other Medical professionals in Gauteng are generally excellent, with many individuals progressing to senior roles within their current organization or transitioning into leadership positions within healthcare organizations. With experience, advanced degrees, or certifications, professionals can explore specialized fields like medical research, policy development, or medical education, which offer greater autonomy and professional fulfillment.
This information provides general career guidance. Actual salaries and requirements vary by employer.
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