Require an Associate Regulatory Affairs Specialist in Nairobi, Kenya
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Experience Required:
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Job Summary
- Support regulatory requirements related to product importation by coordinating with regional Regulatory Affairs teams and product release teams to resolve blocked orders and minimise supply interruptions.
- Collect review and organise regulatory documentation required to support tender submissions across assigned markets.
- Coordinate product registration and renewal activities including sourcing regulatory documents compiling submission packages and tracking approval progress with regulatory authorities.
- Collaborate with global and regional stakeholders to support new product launch plans and regulatory implementation activities.
- Provide regulatory information and documentation required to support country-specific business and compliance projects.
- Maintain regulatory databases trackers and document control systems to ensure data accuracy and audit readiness.
- Monitor registration timelines and follow up with relevant stakeholders to support timely regulatory approvals.
- Support compliance with Medtronic policies quality standards and national regulatory requirements across assigned territories.
- Bachelors degree in Pharmacy Pharmaceutical Sciences Life Sciences Medical Sciences or a related scientific discipline and 1 years of regulatory affairs experience within the medical device pharmaceutical healthcare or life sciences industry.
- Experience supporting regulatory submissions registrations renewals or product compliance activities.
- Fluent written and verbal English communication skills.
- Experience working with Microsoft Office applications including Excel Word and PowerPoint.
- Ability to manage multiple projects deadlines and regulatory documentation requirements simultaneously.
Preferred Qualifications:
- Experience supporting regulatory activities across multiple countries or regions.
- Knowledge of medical device regulatory requirements and product registration processes.
- Experience working with regulatory databases document management systems or compliance tracking tools.
- Experience collaborating with global regional and cross-functional stakeholders.
- Knowledge of tender support processes and importation requirements within healthcare markets.
Required Skills:
Bachelors degree in Pharmacy Pharmaceutical Sciences Life Sciences Medical Sciences or a related scientific discipline and 1 years of regulatory affairs experience within the medical device pharmaceutical healthcare or life sciences industry. Experience supporting regulatory submissions registrations renewals or product compliance activities. Fluent written and verbal English communication skills. Experience working with Microsoft Office applications including Excel Word and PowerPoint. Ability to manage multiple projects deadlines and regulatory documentation requirements simultaneously. Preferred Qualifications: Experience supporting regulatory activities across multiple countries or regions. Knowledge of medical device regulatory requirements and product registration processes. Experience working with regulatory databases document management systems or compliance tracking tools. Experience collaborating with global regional and cross-functional stakeholders. Knowledge of tender support processes and importation requirements within healthcare markets.
