Medical Device Regulatory Affairs Specialist Job Vacancy in Ntchisi, Malawi – Healthcare & Medical Devices

Job Description

Position: Medical Device Regulatory Affairs Specialist

Company: Johnson & Johnson

Location: Ntchisi, Malawi

Experience: 5+ years in medical device regulatory affairs or quality assurance

Education: Bachelor’s degree in Biomedical Engineering, Pharmacy, Life Sciences, or related field. Advanced degree or regulatory affairs certification preferred.

Employment Type: Full-time

Industry: Healthcare & Medical Devices

Department: Regulatory Affairs & Quality Assurance

Vacancies:1

Company Overview

Johnson & Johnson is the world’s largest and most broadly based healthcare company, dedicated to advancing health and well-being for people at every stage of life. For over 130 years, we have blended heart, science, and ingenuity to profoundly change the trajectory of health for humanity. Our Medical Devices segment offers a broad range of products used primarily by healthcare professionals in the fields of orthopedics, surgery, cardiovascular disease, and vision care. In Malawi, we are committed to expanding access to innovative medical technologies while ensuring the highest standards of quality and regulatory compliance. Our presence supports the country’s healthcare infrastructure development, providing life-changing medical devices that improve patient outcomes across diverse communities. We believe our greatest impact happens when we bring together people, resources, and ideas to solve the world’s most significant health challenges.

Job Overview

We are seeking a highly skilled Medical Device Regulatory Affairs Specialist to join our growing team in Ntchisi, Malawi. This critical role will be responsible for developing and executing regulatory strategies to ensure timely approval and compliance of medical devices with the Malawi Medicines and Poisons Board (MPB), regional regulatory bodies, and international standards. The successful candidate will serve as the primary regulatory contact for product registrations, submissions, and ongoing compliance activities, playing a pivotal role in bringing innovative medical technologies to the Malawian market. This position offers an exceptional opportunity to contribute directly to improving healthcare outcomes while developing expertise in a specialized field with global impact. For more Jobs in Malawi and Career Opportunities in Malawi, visit our partner site at https://malawijobsearch.com.

Key Responsibilities

• Develop and implement regulatory strategies for new medical device registrations and license renewals in Malawi and neighboring markets.
• Prepare, compile, and submit regulatory dossiers, technical files, and variations to the Malawi Medicines and Poisons Board and other relevant authorities.
• Maintain current knowledge of evolving medical device regulations, guidelines, and standards in Malawi, the Southern African Development Community (SADC), and internationally.
• Coordinate with global regulatory teams to align local submissions with corporate strategies and ensure consistency in regulatory approaches.
• Manage post-market surveillance activities, including adverse event reporting, field safety corrective actions, and periodic safety update reports.
• Provide regulatory guidance to cross-functional teams including R&D, Quality Assurance, Marketing, and Clinical Affairs throughout the product lifecycle.
• Review and approve labeling, promotional materials, and technical documentation for regulatory compliance.
• Represent the company during regulatory inspections and audits, ensuring all interactions are professional and compliant.
• Establish and maintain positive relationships with regulatory authorities and industry associations.
• Conduct regulatory intelligence activities to anticipate changes that may impact product portfolios and business operations.

Required Skills

• Comprehensive understanding of medical device regulations (Malawi MPB, SADC, ISO 13485, MDR, FDA).
• Excellent technical writing skills with ability to prepare clear, concise regulatory submissions.
• Strong project management capabilities with ability to manage multiple priorities and deadlines.
• Analytical thinking and problem-solving skills to navigate complex regulatory challenges.
• Effective communication and interpersonal skills for collaborating with diverse stakeholders.
• Attention to detail and commitment to quality in all regulatory documentation.
• Proficiency with regulatory information management systems and Microsoft Office Suite.
• Ability to interpret technical, clinical, and scientific data for regulatory purposes.
• Cultural awareness and adaptability to work effectively in the Malawian healthcare context.
• Ethical judgment and integrity in handling confidential regulatory information.

Education

A Bachelor’s degree in Biomedical Engineering, Pharmacy, Life Sciences, Regulatory Affairs, or a related scientific field is required. An advanced degree (Master’s or PhD) in a relevant discipline is highly desirable. Professional certification in regulatory affairs (RAC, RAPS) or quality management systems (ISO 13485 lead auditor) will be considered a significant advantage. Continuous education in regulatory science, medical device technology, or healthcare policy is expected to maintain expertise in this rapidly evolving field.

Experience

Minimum of 5 years of progressive experience in medical device regulatory affairs, with at least 2 years focused on African markets. Demonstrated success in preparing and submitting regulatory dossiers that resulted in product approvals. Experience with Class II and III medical devices is essential. Previous involvement in regulatory inspections and audits is required. Experience working with global regulatory teams and managing regulatory projects across multiple countries is preferred. Knowledge of clinical evaluation reports, post-market surveillance, and vigilance reporting systems is mandatory.

Benefits

• Competitive salary package with performance-based incentives
• Comprehensive health insurance for employee and dependents
• Professional development opportunities and regulatory training programs
• Retirement savings plan with company matching contributions
• Generous paid time off and flexible work arrangements
• Relocation assistance for candidates moving to Ntchisi
• Employee wellness programs and mental health support
• Opportunities for international exposure and career advancement
• Company-sponsored continuing education and certification support
• Participation in employee stock purchase plans

Training

• Comprehensive onboarding program covering company policies and regulatory systems
• Specialized training in Malawi and SADC medical device regulations
• Advanced technical writing workshops for regulatory documentation
• Project management certification opportunities
• Leadership development programs for career progression
• Cross-functional training with quality, clinical, and R&D teams
• Digital tools training for regulatory information management
• Annual regulatory conference attendance and continuing education
• Mentorship program with senior regulatory professionals
• Cultural competency training for effective stakeholder engagement

Working Environment

This position is based in our modern Ntchisi office with state-of-the-art facilities designed to support regulatory excellence. We foster a collaborative, innovative environment where team members are encouraged to share knowledge and develop creative regulatory solutions. The role involves a balanced mix of independent work and cross-functional collaboration, with opportunities for both office-based and remote work arrangements. Our culture emphasizes work-life balance, professional growth, and making a meaningful impact on patient health. You’ll join a diverse team of regulatory professionals committed to advancing medical technology access in Malawi while maintaining the highest standards of compliance and ethics.

Application Process

Interested candidates should submit a comprehensive CV, cover letter detailing relevant regulatory experience, and copies of academic certificates through our online application portal. The selection process will include initial screening, technical assessment, panel interviews with regulatory and cross-functional leaders, and final interviews with senior management. Only shortlisted candidates will be contacted for further assessment. We encourage applications from qualified Malawian nationals and residents who are passionate about contributing to healthcare advancement through regulatory excellence. For additional Employment in Malawi resources and Job Vacancy in Malawi listings, explore https://www.zambiajobssearch.com/.

Equal Opportunity Statement

Johnson & Johnson is an equal opportunity employer committed to creating an inclusive working environment. We value diversity and do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We actively encourage applications from women, people with disabilities, and all qualified individuals who can contribute to our mission of advancing health for humanity. Our recruitment and promotion practices are based on merit, qualifications, and business needs. We provide reasonable accommodations for applicants with disabilities throughout the recruitment process.