What Jobs are available for Medical Devices in Kenya?

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with ISO 13485 and FDA regulations.
• Lead and manage internal audits to ensure compliance and identify areas for improvement.
• Oversee external audits by regulatory bodies and customers.
• Manage the CAPA system, including investigation, root cause analysis, and implementation of corrective actions.
• Administer the document control and change control processes.
• Oversee the handling and investigation of customer complaints and adverse events.
• Collaborate with R&D, manufacturing, and regulatory affairs to ensure product quality throughout the lifecycle.
• Participate in product development teams, providing QA input and guidance.
• Conduct risk assessments and ensure risk management processes are effective.
• Train employees on quality system requirements and best practices.
• Monitor key quality metrics and report on QMS performance to senior management.
• Support regulatory submissions and interactions with health authorities.
• Stay current with relevant regulations, standards, and industry trends.
• Foster a strong quality culture throughout the organization.
• Manage and develop the Quality Assurance team.

• Bachelor's degree in Engineering, Life Sciences, or a related technical field. Master's degree preferred.
• Minimum of 7 years of experience in Quality Assurance within the medical device industry.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant international medical device regulations.
• Proven experience in establishing and maintaining robust QMS.
• Experience leading internal and external audits.
• Strong understanding of product development, risk management, and validation processes.
• Excellent leadership, team management, and interpersonal skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Proficiency in CAPA, change control, and document management systems.
• Effective communication and reporting skills.
• Ability to work effectively in a hybrid work environment.
• Relevant certifications (e.g., ASQ Certified Quality Engineer/Manager) are a plus.

• Promote and sell pharmaceutical products and medical devices to healthcare professionals.
• Build and maintain strong relationships with physicians, hospital staff, and other key decision-makers.
• Conduct virtual presentations and product demonstrations to showcase device capabilities.
• Provide comprehensive product information, clinical data, and technical support to clients.
• Achieve and exceed sales targets within the assigned territory.
• Develop and implement strategic sales plans to penetrate new accounts and expand market share.
• Monitor market trends, competitor activities, and customer needs.
• Negotiate pricing and contract terms with clients.
• Collaborate with marketing teams on product launch strategies and promotional activities.
• Maintain accurate records of sales activities and customer interactions in the CRM system.

• Bachelor's degree in Pharmacy, Life Sciences, Business, or a related field.
• Proven experience in pharmaceutical or medical device sales.
• Demonstrated success in achieving and exceeding sales targets.
• Strong understanding of the healthcare industry and medical terminology.
• Excellent communication, negotiation, and presentation skills.
• Proficiency with CRM software (e.g., Salesforce) and virtual meeting platforms.
• Ability to work independently, manage time effectively, and travel as required.
• High level of professionalism and ethical conduct.

Our client is a leading player in the fast-paced FMCG sector, dedicated to ensuring a favorable operating environment where they can thrive. With a significant presence across Kenya, Tanzania, and Uganda, they are committed to shaping legislative and regulatory developments to foster sustainable growth and maintain market competitiveness. They operate with a strong focus on responsible business practices and are aligned with global best practices.

Are you a strategic and influential leader passionate about navigating complex regulatory landscapes? Join our client as a Senior Manager, Regulatory Affairs & Policy, and play a pivotal role in shaping their operational environment across East Africa. This is a unique opportunity to drive impactful change, influence policy, and safeguard the company's reputation and bottom line. You will be instrumental in developing and executing strategies that ensure compliance, mitigate risks, and facilitate market access in a dynamic and heavily regulated industry. If you thrive on tackling challenges, building strong stakeholder relationships, and contributing to the strategic direction of a prominent FMCG business, this role is for you.

Responsibilities:

Develop and implement targeted strategies to address specific regulatory challenges and analyze the economic impact of proposed policy changes in Kenya, Tanzania, and Uganda, aligning with global best practices.

Provide a coordinated and integrated organizational approach to anticipate, analyze, and influence legislative and regulatory development and its impact on both business performance and reputation.

Offer guidance and support in the implementation and maintenance of strategies related to regulatory issues, trade, and tax policies to secure competitiveness.

Develop, implement, and monitor anti-counterfeit and anti-parallel business measures and strategies to facilitate market access and mitigate potential risks.

Manage the company's regulatory risk radar, providing early warning and visibility on key regulatory risks to the business.

Ensure early identification of regulatory business risks and align internal stakeholders to address them within the company's business plans.

Manage stakeholder engagements and foster strong relationships with key policy and regulatory stakeholders, representing the company in industry associations and advocating for favorable positions.

Implement best practice methods for issue-based lobbying, including defining company positions, counter-arguments, and stakeholder engagement plans.

Engage with government departments, regulators, industry bodies, and other external stakeholders to advocate on key regulatory issues.

Assist in influencing public policy to support business objectives and provide policy advocacy to regional business units on key issues.

Participate in regulatory forums, ensuring all prioritized regulatory issues are addressed and internal stakeholders are kept informed.

Requirements:

Must-Haves:

Academic Qualifications: Bachelor's Degree in Economics, Law, Public Policy, Political Science, International Relations, or a related discipline.

Professional Qualifications: Member of the Law Society of Kenya.

Experience: At least 6 years of relevant experience, with a minimum of 2 years in a management role within Government, Alcohol, Tobacco, Pharmaceuticals, or another heavily regulated industry, an international institution, or FMCG.

Regulatory Understanding: A good understanding of economic, commercial, and political dynamics in the countries of operation.

Analytical Skills: Ability to undertake research and draft position papers, analyze the impact of regulatory change, and analyze data to make informed decisions.

Policy Knowledge: Knowledge of public policy issues and legislative and political processes.

• Prepare, review, and submit regulatory dossiers for new product registrations and variations.
• Monitor and interpret evolving regulatory requirements in relevant markets.
• Liaise with regulatory agencies to facilitate product approvals and address inquiries.
• Develop and maintain regulatory strategies for product lifecycle management.
• Ensure compliance with local and international pharmaceutical regulations, including Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
• Collaborate with R&D, Quality Assurance, and Marketing departments to ensure regulatory requirements are integrated into product development and commercialization processes.
• Provide regulatory guidance and support to cross-functional teams.
• Maintain accurate and up-to-date regulatory documentation and databases.
• Conduct regulatory assessments for new product development projects and line extensions.
• Manage post-approval regulatory activities, including annual reports and labeling updates.
• Participate in regulatory inspections and audits.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is a plus.
• Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
• Solid understanding of pharmaceutical regulatory frameworks in key markets (e.g., KEBS, EMA, FDA).
• Experience in preparing and submitting Common Technical Document (CTD) modules.
• Excellent knowledge of drug development processes and product lifecycle management.
• Strong analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to clearly articulate complex regulatory information.
• Proficiency in regulatory information management systems.
• Ability to work independently and collaboratively in a team environment.
• High level of accuracy and meticulous attention to detail.
• Adaptability to changing regulatory landscapes and business priorities.