SDG Quality and Regulatory Affairs Manager Sub-Saharan Africa at Thermo Fisher Scientific

Discover Impactful Work:

The primary responsibility of this role is to be the subject matter expert to develop, and implement quality and regulatory strategies, to secure and maintain the marketing and sales of Thermo Fisher Scientific products in Sub-Saharan Africa.

The position is part of the Speciality Diagnostics Group, Europe, Middle East and Africa (EMEA) Quality and Regulatory team.  You will work alongside SDG and divisional quality and regulatory, commercial, operations and legal teams as part of the Thermo Fisher Scientific organisation.

A day in the Life:

Quality

• Drive company compliance and upkeep to the Quality Management system in accordance with ISO 9001, and ISO13485, holding responsibility of implementation of actions as Quality Management Representative, for the Susan Street Site
• Provide Quality Management System strategic direction, working with support functions to promote consistent application of quality processes across the site, maintaining an “inspection ready” state.
• Prepare site quality objectives, developing and maintaining an efficient documentation and communication system, including corporate tools and resources, ensuring reporting metrics are supported and accurately assembled.
• Plan and participate in internal ISO audits according to a pre-prepared and published audit programme.
• Where non-conformities or Corrective and Preventative Actions arise, take initiative to collaborate with departments to support root cause analysis and implement associated actions to address and verify effectives in line with corporate policy.
• Complete the process for incident reporting, recall and post market surveillance.
• Drive, champion & promote quality practices and behaviours across the local site.

Regulatory

• SDG regulatory lead for Sub-Saharan Africa and point of contact for SDG divisional regulatory departments, communicating regulatory changes, risks, and challenges, that impact the Thermo Fisher product portfolio, to ensure the company remains leaders in their field of business.
• Collaborate with the commercial organisation to develop and implement commercial and regulatory strategies to secure and maintain the marketing and sales of Thermo Fisher Scientific products.
• Plan, lead and prepare country specific registration packages to meet product time-to-market strategies according to published regulations across Sub-Saharan Africa. Present regular progress reports and call out any issues for resolution.
• Engage regulators, when necessary, in face-to-face, oral, and written communications to discuss pending or new submissions, and associated regulatory requirements.
• Participate & represent SDG (and other Thermo Fisher company groups as the need arises), in IVD industry associations, conferences & meetings.

Education

Undergraduate Degree in science, engineering, or related field

Experience

• 6 years experience in IVDs or medical devices
• OR Advanced Degree and 4 years experience

Knowledge, Skills, Abilities

• Have a keen understanding of regulatory requirements to sell company products across defined priority territories within the African continent.
• Practical knowledge of product, process improvement methods to participate in cross functional, multi-site Speciality Diagnostic Group projects.
• Strong interpersonal skills with both internal and external customers, with the ability to deliver messages clearly and succinctly.
• Able to work in a matrix environment.
• Fluency in English language.