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Quality and Regulatory Affairs Specialist - Medicines and Medical Devices

Join to apply for the Quality and Regulatory Affairs Specialist - Medicines and Medical Devices role at Solventum. Thank you for your interest in working for our Company.

Recruiting the right talent is crucial to our goals.

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.

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

1. Compilation, submission, and maintenance of dossiers for Medicines and Medical Device registration in SA and SADC countries
2. Change Management – ability to stay updated with changes and / or emerging regulations
3. Maintenance of ISO: Certification
4. Managing SOPs, WIs
5. Handling Customer Complaints, FSCA, Adverse Events, and Recalls
6. Managing Vendors / Suppliers and Channel Partners
7. Hosting Internal and external audits

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

1. Strong Knowledge of SA and SSA Regulatory Landscape – Legislations, Regulations, and guidelines
2. Qualified Pharmacist registered with South African Pharmacy Council
3. Experience in MedTech industry
4. Wound care products knowledge will be an added advantage
5. Bachelor Degree or higher in Pharmacy
6. ISO: 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

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. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of solventum.com.