Regulatory Affairs Specialist (m/f/x)*

Solventum; Sandton; Ibrido; ZAR 750.000 - 900.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid Eligible

Descrizione del lavoro

Solventum, a healthcare company, is seeking a Regulatory Affairs and Quality Compliance Specialist to manage regulatory projects for South Africa and Sub-Saharan regions. The role ensures ongoing compliance with regulatory and quality systems and reports on adverse events and complaints.

The position requires a Pharmacist registration, Medicines Registration experience, and a strong quality assurance background, with hybrid work options and travel limited to business needs.

Competenze

• Bachelor’s Degree or higher: Pharmacist.
• Minimum 2 years’ experience in Medicines Registration.
• Minimum 5 years’ experience in Quality Assurance.
• Registered Pharmacist (with SAPC).

Mansioni

• Deputy Responsible Pharmacist and quality management representative to ensure compliance with local regulatory and quality requirements.
• Manage and oversee all regulatory and quality projects for South Africa and Sub-Saharan countries.
• Secure regulatory licences and certificates.
• Ensure timely regulatory submissions and maintain licences and certificates through annual retention, amendments, rebranding and renewals.
• Monitor regulatory landscape and changes across internal systems and regulatory authority websites.
• Lead regulatory projects to support business opportunities via registration/listing of products.
• Suggest and test ideas on technical and regulatory opportunities.
• Support ISO 13485:2016 certification maintenance.
• Assist external audits and audits of channel partners and third-party distribution centres.
• Ensure timely reporting of complaints and adverse events per procedures and regulatory requirements.
• Support export-model, re-branding, DC separation and spin-off projects.
• Support bids and tenders.

Descrizione del lavoro

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

As a Regulatory Affairs And Quality Compliance 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 By

• 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.

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.

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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 by clicking here. Before submitting your application you will be asked to confirm your agreement with the terms.