Job Description
Position:Regulatory Affairs Manager
Company:Johnson & Johnson Nigeria
Location:Enugu, Nigeria
Experience:5-8 years
Education:Bachelor’s degree in Pharmacy, Biomedical Engineering, or related field; Master’s preferred
Employment Type:Full-time
Industry:Medical Devices
Department:Regulatory Affairs
Salary:₦2,500,000 – ₦3,500,000 per annum
Vacancies:1
Company Overview
Johnson & Johnson Nigeria is a leading multinational healthcare company dedicated to improving the health and well-being of people worldwide. With a strong presence in Nigeria for over three decades, the company operates across pharmaceuticals, consumer health, and medical devices. The Medical Devices division focuses on innovative solutions ranging from surgical instruments to advanced diagnostic equipment, serving hospitals, clinics, and health centers across the country. As part of its commitment to excellence, Johnson & Johnson Nigeria invests heavily in research, development, and regulatory compliance to ensure that every product meets the highest safety and efficacy standards. This commitment creates a dynamic environment for professionals seeking career growth in a globally recognized organization.
Job Overview
The Regulatory Affairs Manager will lead the strategy and execution of regulatory activities for the Medical Devices portfolio in Nigeria. Reporting to the Regional Regulatory Director, you will be responsible for ensuring that all products comply with local and international regulations, facilitating market entry, and maintaining product registrations. This role is pivotal in bridging the gap between product development, quality assurance, and government agencies, thereby supporting Johnson & Johnson’s mission to deliver safe and effective medical devices. For more information about our company and other career opportunities, visit Nigeria Job Search. This position offers a unique chance to influence the healthcare landscape in Nigeria while advancing your professional expertise.
Key Responsibilities
- Develop and implement regulatory strategies for new and existing medical device products to achieve timely market approvals.
- Prepare, review, and submit registration dossiers, technical files, and post‑market surveillance reports to the National Agency for Food and Drug Administration and Control (NAFDAC) and other relevant authorities.
- Maintain up‑to‑date knowledge of Nigerian medical device regulations, international standards (ISO 13485, IEC 60601), and emerging compliance trends.
- Collaborate with cross‑functional teams including R&D, Quality Assurance, Marketing, and Legal to ensure regulatory requirements are integrated throughout the product lifecycle.
- Lead interactions with regulatory bodies, respond to queries, and manage audit inspections.
- Monitor and assess changes in regulatory policies and advise senior management on potential impacts.
- Develop and deliver internal training programs on regulatory affairs best practices.
- Oversee the maintenance of product registration databases and ensure accurate documentation.
Required Skills
- Strong understanding of Nigerian medical device regulations and international standards.
- Excellent written and verbal communication skills for preparing technical documents and liaising with authorities.
- Analytical mindset with the ability to interpret complex regulatory guidelines.
- Project management expertise, including timeline development and stakeholder coordination.
- Proficiency in regulatory submission software and Microsoft Office Suite.
- Attention to detail and high level of organizational skills.
- Ability to work independently and lead a multidisciplinary team.
Education
A minimum of a Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related discipline is required. A Master’s degree or professional certification such as RAC (Regulatory Affairs Certification) is highly desirable and will be considered an advantage during the selection process.
Experience
Applicants must have 5 to 8 years of progressive experience in regulatory affairs within the medical device industry, preferably with direct exposure to the Nigerian market. Experience in managing product registrations, post‑market surveillance, and regulatory audits is essential.
Salary
The compensation package ranges from ₦2,500,000 to ₦3,500,000 per annum, commensurate with experience and qualifications. The package includes performance‑based bonuses, health insurance, and a pension scheme.
Benefits
- Comprehensive health and dental coverage.
- Retirement savings plan with employer contribution.
- Annual performance bonus.
- Paid parental and sick leave.
- Employee assistance program.
- Access to global learning platforms and professional development resources.
Training
- On‑boarding program covering company policies, product portfolio, and regulatory landscape.
- Continuous professional development courses in regulatory science, quality management, and leadership.
- Opportunities to attend international conferences and workshops.
Working Environment
Johnson & Johnson Nigeria offers a collaborative, inclusive, and innovative workplace where diversity of thought is celebrated. The Enugu office provides modern facilities, flexible working arrangements, and a culture that encourages knowledge sharing and continuous improvement. Employees are empowered to make decisions that positively impact patient outcomes and business success.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online portal on our website. 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
Johnson & Johnson Nigeria is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees regardless of gender, race, religion, disability, or sexual orientation. All qualified applicants will receive consideration for employment.