Roche
Regulatory and QA Manager
Kenya
The Position
Regulatory and QA Manager
Kenya
The Position
Key responsibilities for this position include, but are not limited to:
- Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
- Establish and foster relationships with local medical device and IVD industry groups and work with the industry peers to lobby the Ministry of Health in matters of regulatory and marketing code compliance.
- Ensure product registration is submitted, reviewed and renewed as required in conjunction with Export distributors.
- Engage product managers on laws and regulations that would affect business policies and processes.
- Assisting with the approval advertising/promotional generated for Export market items for compliance before release
- Responsible for the supervision, monitoring and improvements for handling local inquiries and complaints and escalating all PCC to Regional Local Safety Officer
- In case of recall for legal reasons: ensure immediate notification of Competent Authority on the basis of information provided by the Business Area Safety Board in conjunction with the Head of the Division
The successful candidate should be in possession of :
- Medical/ Science Degree e.g. Pharmacy
- Experience of 2-3 years in the diagnostics/Pharmaceuticals industry preferred.
- 1 – 3 years in Regulatory Affairs and Quality Assurance experience
- Ability to build and foster relationships with clinicians, regulatory officials and Key opinion leaders in health sector
Who you are
You’re someone who wants to influence your own development.
You’re looking for a
company where you have the opportunity to pursue your interests across
functions and geographies, and where a job title is not considered the
final definition of who you are, but the starting point.
The next step is yours.
To apply online today and learn about other exciting positions, please visit www.careers.roche.com
Alternatively forward your application together with a detailed CV for the attention: Refilwe Nthongoa, on careers.dia_sa@roche.com by the 19th July 2013.
Late applications will not be considered.
If you have not heard from us two weeks after the closing date, kindly consider your application as unsuccessful.