International Regulatory Affairs Manager – Medical Devices

Patricia
  • Post Date: August 7, 2019
  • Apply Before: August 31, 2019
  • Applications 0
  • Views 472
Job Overview

International Regulatory Affairs Manager – Medical Devices 

Paulshof, Gauteng

Position Overview:

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

 

If you do meet all the requirements and you are interested, kindly contact Patricia Koekemoer on 012 991 5854 or send an email to patricia@prosourcing.co.za

 

Job Detail
  • Career LevelManagement
  • Experience8 Years +
  • BEE – African Only PositionNo
  • INDUSTRYMultinational
  • QualificationBachelor Degree
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