Regulatory Affairs Specialist Job Vacancy in Matsapha, Eswatini – Medical Devices

Job Description

Position: Regulatory Affairs Specialist

Company: Medtronic Eswatini

Location: Matsapha, Eswatini

Experience: 5+ years in regulatory affairs within medical device industry

Education: Bachelor’s degree in Life Sciences, Engineering, or related field; Master’s preferred

Employment Type: Full-time

Industry: Medical Devices

Department: Regulatory Affairs

Salary: SSP 250,000 – SSP 350,000 per month

Vacancies:1

Company Overview

Medtronic Eswatini is a leading global medical technology company dedicated to improving patient outcomes through innovative devices and therapies. With a strong presence across Africa, Medtronic brings cutting‑edge solutions to hospitals, clinics, and health systems, fostering a culture of excellence, integrity, and collaboration. The Matsapha facility serves as a regional hub for product registration, compliance, and market support, playing a pivotal role in ensuring that life‑saving technologies meet the highest regulatory standards. As part of Medtronic’s commitment to local talent development, the company offers robust career pathways, mentorship programs, and a dynamic work environment that encourages continuous learning and professional growth. This position contributes directly to Medtronic’s mission of alleviating disease and enhancing quality of life throughout Eswatini and the broader Southern African region.

Job Overview

The Regulatory Affairs Specialist will lead the preparation, submission, and maintenance of regulatory dossiers for Medtronic’s medical devices in Eswatini and neighboring markets. This role ensures compliance with national and international regulations, collaborates with cross‑functional teams, and acts as the primary liaison with health authorities. The specialist will also monitor regulatory changes, provide strategic guidance, and support product launches to guarantee timely market access. This is a critical function that underpins Medtronic’s ability to deliver innovative health solutions, making it an exciting opportunity for professionals seeking to make a tangible impact on healthcare delivery. For more information about Medtronic’s global initiatives, visit https://eswatinijobsearch.com.

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Key Responsibilities

• Prepare and submit regulatory applications, amendments, and renewals for medical devices in compliance with Eswatini’s Medicines and Related Substances Act.
• Maintain and update product dossiers, technical files, and labeling to reflect current regulatory requirements.
• Conduct regulatory intelligence to track changes in local and regional legislation, standards, and guidance documents.
• Collaborate with R&D, Quality, Clinical, and Marketing teams to ensure regulatory considerations are integrated throughout product development.
• Serve as the primary point of contact with the Eswatini Medicines Regulatory Authority and other relevant health agencies.
• Develop and deliver regulatory training sessions for internal stakeholders.
• Support post‑market surveillance activities, including adverse event reporting and product recalls.
• Prepare regulatory strategy documents to facilitate market entry and expansion across Southern Africa.

Required Skills

• In‑depth knowledge of medical device regulations in Eswatini, SADC, and international standards such as ISO 13485 and IEC 60601.
• Strong analytical and problem‑solving abilities with meticulous attention to detail.
• Excellent written and verbal communication skills for drafting clear regulatory submissions.
• Proficiency in regulatory software tools and document management systems.
• Ability to work cross‑functionally and manage multiple projects under tight deadlines.
• Negotiation and stakeholder management skills for effective liaison with authorities.
• Fluency in English; knowledge of SiSwati is an advantage.
• Proven track record of successful product registrations in emerging markets.

Education

A Bachelor’s degree in Biomedical Engineering, Pharmacy, Life Sciences, or a related discipline is required. A Master’s degree or professional certification (e.g., RAPS, RAC) is highly desirable and demonstrates a commitment to regulatory excellence.

Experience

Applicants must have a minimum of five years of hands‑on experience in regulatory affairs for medical devices, preferably within an international organization. Experience with submissions to both national authorities and regional bodies (e.g., SADC) will be considered a strong asset.

Salary

The compensation package ranges from SSP 250,000 to SSP 350,000 per month, commensurate with experience and qualifications. The package includes performance‑based incentives, health insurance, and a pension scheme.

Benefits

• Comprehensive medical and dental coverage for employee and dependents.
• Retirement savings plan with company matching contributions.
• Annual performance bonus tied to individual and company goals.
• Paid parental leave and generous vacation entitlement.
• Employee assistance program and wellness initiatives.
• Opportunities for international assignments and career advancement.

Training

• On‑boarding program covering Medtronic’s compliance framework and product portfolio.
• Continuous professional development courses in regulatory science and global standards.
• Access to industry conferences, webinars, and certification programs.
• Mentorship pairing with senior regulatory leaders across the Medtronic network.

Working Environment

Medtronic Eswatini offers a collaborative, inclusive, and safety‑focused workplace. Employees benefit from modern office facilities, flexible working arrangements, and a culture that values diversity and innovation. The organization promotes work‑life balance and encourages employees to contribute ideas that drive both personal and organizational growth.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the Medtronic careers portal. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for a virtual interview followed by an on‑site assessment.

Equal Opportunity Statement

Medtronic Eswatini is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, race, religion, age, disability, or sexual orientation. All qualified applicants will receive consideration for employment without regard to any protected characteristic.

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