Regulatory Affairs Specialist needed at Medtronic

A Day in the Life

• You are an administratively proficient person, who despite routine also likes to interact across the globe to complete work, being able to be part of a team that delivers on time sensitive projects. Your laptop is your companion and gateway to work.
• The purpose of the job is to ensure regulatory compliance for the region of responsibility, managing projects and assignments to ensure that Medtronic therapies are approved, and compliance is maintained across all facets of premarket and post market surveillance and vigilance. The position is a hybrid (office and home) position based in Midrand, Gauteng and while travel is minimal, it cannot be discounted.

Responsibilities may include the following and other duties may be assigned:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications. 

Required Knowledge and Experience:

• 4+ years of experience in Regulatory Affairs area with advanced knowledge of job area combining breadth and depth. Knowledge of project management would be advantageous.
• Bachelor’s Degree in a relevant field, Bachelor’s Degree in Pharma is appreciated.
• Ability to deal with multiple complex projects / issues simultaneously.
• Strong MS office skills, with SAP experience an advantage.
• Strong Integrity and ethical values.
• Team player.