Regulatory Affairs Specialist (m/f/x)*

ZAF Systagenix Wound Management (South Africa) (Proprietary) Limited; Randburg; Hybrid; ZAR 900,000 - 1,200,000; Full time

Job summary

Solventum is seeking a Deputy Responsible Pharmacist and Quality Management representative to ensure compliance with local regulatory and quality requirements while managing regulatory projects for South Africa and Sub-Saharan regions.

This hybrid role requires a registered Pharmacist with SAPC, 2+ years in medicines registration, and 5+ years in Quality Assurance, with limited domestic travel.

Qualifications

• Bachelor’s Degree or higher: Pharmacist.
• Minimum 2 years’ medicines registration experience.
• Minimum 5 years’ experience in Quality Assurance.

Responsibilities

• Securing all applicable regulatory licences and certificates.
• Ensuring timely regulatory submissions and maintaining the validity of licences and certificates, including annual retention, amendments, rebranding and renewals.
• Maintaining real-time monitoring of the regulatory landscape and tracking legislative and regulatory changes across all relevant internal systems and regulatory authority websites.
• Leading regulatory projects to support business opportunities through the timely registration and/or listing of products.
• Developing awareness of technical and regulatory opportunities and taking the initiative to suggest and test ideas.
• Supporting the maintenance of Solventum SA's ISO 13485:2016 certification.
• Supporting the management of company external audits and conducting audits of channel partners and third‑party distribution centres (DCs).
• Ensuring the timely reporting of complaints and adverse events in accordance with internal systems and procedures, as well as applicable regulatory requirements.
• Supporting export-model, re-branding, DC separation and other spin‑off‑related projects.
• Supporting bids and tenders.

Skills

Medicines Registration experience

Quality Assurance

Education

Bachelor’s Degree in Pharmacy

Job description

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. 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

Deputy Responsible Pharmacist and quality management representative to ensure compliance with the local regulatory and quality requirements. Manage and oversee all the regulatory and quality projects for South Africa and Sub-Saharan countries

• Securing all applicable regulatory licences and certificates.
• Ensuring timely regulatory submissions and maintaining the validity of licences and certificates, including annual retention, amendments, rebranding and renewals.
• Maintaining real‑time monitoring of the regulatory landscape and tracking legislative and regulatory changes across all relevant internal systems and regulatory authority websites.
• Leading regulatory projects to support business opportunities through the timely registration and/or listing of products.
• Developing awareness of technical and regulatory opportunities and taking the initiative to suggest and test ideas.
• Supporting the maintenance of Solventum SA's ISO 13485:2016 certification.
• Supporting the management of company external audits and conducting audits of channel partners and third‑party distribution centres (DCs).
• Ensuring the timely reporting of complaints and adverse events in accordance with internal systems and procedures, as well as applicable regulatory requirements.
• Supporting export‑model, re‑branding, DC separation and other spin‑off‑related projects.
• Supporting bids and tenders.

Your Skills and Expertise

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

• Bachelor’s Degree or higher: Pharmacist
• Minimum 2 years’ experience in Medicines Registration experience
• Minimum 5 years’ experience in Quality Assurance

In addition to the above requirements, the following are also required:

• Registered Pharmacist (with SAPC)
• Work Location: Systagenix Wound Management (South Africa) Pty Ltd
• Work Type: Hybrid
• Eligible Travel: Limited amount of travel, 5-10% (domestic), in line with business needs.
• Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

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.

About Solventum

A new healthcare company with a rich history. With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges.

20,000+ employees worldwide.

Solventum relies on the courage and the boundless insights of professionals worldwide to achieve exceptional results for our customers and those who rely on them.

Healthcare that leads with heart and humility starts with listening and never finishes, only evolves.

As long as healthcare challenges remain unsolved, we will be here, united by empathy and a relentless belief that countless lives are improved through our work.

Operations in 38 countries. Driven by our dedication to improved outcomes for all we serve, we break through by making unprecedented connections that impact lives.

In more than 300 offices and facilities around the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders. To realize our shared vision, we harness diverse talents and perspectives from every background to not only address our customers' most urgent priorities but anticipate the needs of the future