Overview
Quality and Regulatory Affairs Specialist- Medicines and Medical Devices Jobs in Sandton at Solventum
Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description:
3M Health Care is now Solventum
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 Role
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.
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. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
Solventum Global Terms of Use and Privacy Statement
Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.
Please access the linked document, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the
terms.
Title: Quality and Regulatory Affairs Specialist- Medicines and Medical Devices
Company: Solventum
Location: Sandton
