International Regulatory Affairs Manager – Medical Devices
Our client is a global Medical Device Manufacturer and Distributor of leading medical devices and they have created a new opportunity for an International Regulatory Affairs Manager.
To prepare the regulatory submissions and interact with regulatory agencies and health authorities to obtain and maintain product approvals with a focus on African countries.
One will assist with ROW submissions as required. Participate in international regulatory intelligence groups and represent Regulatory Affairs on the product life-cycle management teams as needed.
Experience, Qualifications and Skills Required:
- Bachelor’s degree in a Life Science or related field preferred OR equivalent combination of education and experience to perform at this level
- Minimum of 5-6 years of experience in regulatory / quality or related departments within an IVD or medical device industry
- Minimum of 3-5 years management experience with at least 2-3 direct reports
Knowledge and skills:
- Must be detail oriented with well-developed organizational and analytical skills
- Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
- Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment
- Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
- Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations
- Able to confidently deal with ambiguous issues and provide input towards suitable actions
- Strong oral and written communication and presentation skills
- Effective communicator of technical and non-technical information
- Ability to work in a self-directed manner to see issues through to completion
- IVD product experience is highly preferred
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