Senior Regulatory Affairs Specialist

Medtronic

  • Johannesburg, Gauteng
  • Permanent
  • Full-time
  • 7 days ago
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.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:
  • 5+ 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
Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.Learn more about our business, mission, and our commitment to diversity

Medtronic