Quality and Regulatory Affairs Specialist- Medicines and Medical Devices

4 weeks ago


Sandton, South Africa Solventum Full time

**3M**H**ealth**C**are is now**S**olventum**

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

**The Impact You’ll Make in this Rol**e

We are looking for a **Medicines and Medical**Devices Quality & Regulatory Specialist** to join us in Solventum Johannesburg. The role will play an important role in ensuring compliance with established quality principles and promote continuous improvements to productivity, quality, and customer satisfaction.

As a Regulatory Affairs and Quality Assurance Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here,
you will make an impact:

- Compilation, submission and maintenance of dossiers for Medicines and Medical Device registration in SA and SADC countries
- Change Management - ability to stay updated with changes and/or emerging
regulations
- Maintenance of ISO 13485: 2016 Certification
- Managing SOP’s, WI
- Handling Customer Complaints, FSCA, Adverse Events and Recalls
- Managing Vendors/Suppliers and Channel Partners
- Hosting Internal and external audits

**Your Skills and Expertise**

To set you up for success in this role from day one, Solventum requires (at a minimum) the following:

- Strong Knowledge of SA and SSA Regulatory Landscape - Legislations, Regulations and guidelines
- Qualified Pharmacist registered with South African Pharmacy Council
- Experience in MedTech industry. Wound care products knowledge will be an added advantage
- Bachelor Degree or higher in Pharmacy
- ISO 13485:2016 QMS experience

**Work location**:

- Hybrid (Job Duties allow for some remote work but require travel to On-site Office around 3 days per week)
- Site info: Solventum South Africa, Design Quarters, Fourways, Johannesburg

Supporting Your Well-being
Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are
comparable in size and scope.

Diversity & Inclusion
(*) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

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