Type your keywords in the search box above

International Regulatory Affairs Manager – Medical Devices

Description: 

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

Employer: 

Professional Sourcing

Location: 

Johannesburg

Salary: 

R 650 000-00 per annum

Job Reference: 

580017