Quality and Regulatory Officer

4 months ago

Pretoria, South Africa Arjo Full time

**Empowering careers at ARJO**

**At Arjo, we know what moves us. We go above and beyond for people facing mobility challenges. We take every opportunity to work and grow as one team and take pride in sharing our knowledge and experience. Does that sound like something that moves you too?**

**This could be your opportunity to begin a challenging and rewarding career in a healthcare company that empowers movement for people with mobility challenges.**

**Empowering careers at ARJO**

**At Arjo, we know what moves us. We go above and beyond for people facing mobility challenges. We take every opportunity to work and grow as one team and take pride in sharing our knowledge and experience. Does that sound like something that moves you too?**

**This could be your opportunity to begin a challenging and rewarding career in a healthcare company that empowers movement for people with mobility challenges.**

The purpose of the **Quality and Regulatory Officer (Contract Role) **is to provide support to the business on all aspects of Quality Assurance and Regulatory Affairs, and complaints handling in Africa.

As the Quality and Regulatory Officer you will be responsible for:
**Essential Duties and Responsibilities**:

- Execute and assist in the design implementation, maintenance and certification of Quality Management policies and procedures to meet the requirements of ISO9001, ISO13485 and/or as directed by management.
- Ensure Global Management system SOP and associated documents are embedded in local system and distributed to relevant or affected management and staff.
- Integrate requirements of SOP124 into the QMS and ensure on going compliance.
- Monitor publication of Global Management system SOP and associated documents.
- Assist with ensuring Management and staff are trained and fully understand their role in the quality management systems, Global Management system SOP and associated documents
- Assist with ensuring training records for all staff effected by the quality system are kept and maintained.
- Efficiently manage non-conformances within the business.
- Maintain good document & data control.
- Assist in conducting internal quality audits, supplier quality audits as required,
- And Distributor audits as required
- Assist and support with regulatory and compliance activities and requirement for the region
- Ensure all components and activities linked to trackwise is executed timeously and effectively as per the local and global standards
- Ensure all Post Market Activities such as incident reports, field actions, are executed timeously and efficiently with all internal and external stakeholders
- Monitor projects to maximise the probability for project objectives, success criteria, quality and time frames to be achieved.
- Maintain strong business relationships with existing customers by ensuring compliance with all contract requirements, obtaining feedback and maintaining quality work.

**Requirements**:

- 3+ years experience in Africa Regulatory Affairs for Medical Devices.
- High knowledge of Quality and Regulatory systems.
- Be knowledgeable of current risk management standards, principles and frameworks.
- Reviewing and completing activities according to previously defined priorities.
- Experience in Health Care and/or Medical Devices industries.

**What we will offer in return**

You will support our vision to be the most trusted partner in driving healthier outcomes for people facing mobility challenges. In return, we recognize and value our global employees. You will have our full support, training and opportunities for professional development.

**Why diversity matters to us**

At Arjo, we believe in the power of diversity. We strongly encourage applicants from all parts of society, which means building a more diverse, equitable, inclusive and engaging environment - not only in the workplace, but also within the communities that we serve, work in and live in. We achieve this through a culture and mindset that values the uniqueness of all our people.

**About Arjo**

**At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.

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