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
We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.
We are looking for a dedicated and detail-oriented PMV (Post-Market Vigilance) Associate to join our team. The successful candidate will be responsible for managing various post-market vigilance activities, including managing FCA (Field Corrective Actions), reviewing reportable decisions as needed, submitting regulatory reports, addressing regulatory inquiries, handling CAPA (Corrective and Preventative Actions) and projects, as well as engaging with local field staff, among other duties. This role requires strong analytical skills, attention to detail, and the ability to work collaboratively with internal stakeholders such as local and global operating units and the PMV team and as well as external stakeholders such as TGA and Medsafe.
Responsibilities may include the following and other duties may be assigned:
-
Oversee and manage all aspects of FCA (Field Corrective Actions) to ensure compliance with regulatory
-
Provide second opinions on regulatory decisions to ensure accuracy and compliance.
-
Submit Regulatory reports to regulatory authorities
-
Handle and respond to regulatory inquiries in a timely and efficient manner.
-
Develop and implement Corrective and Preventive Actions (CAPA) to address regulatory issues and improve processes.
-
Manage and coordinate different aspects of regulatory projects, ensuring they are completed on time.
-
Continuously engage with local field staff to ensure alignment and completion of various activities involved in field corrective actions and complaints.
Required Knowledge and Experience:
-
Bachelor's degree in a related field (e.g., Life Sciences, Pharmacy, Regulatory Affairs)
-
0-1 year of experience in regulatory affairs or a related field.
-
Knowledge of regulatory requirements and guidelines.
-
Excellent communication and interpersonal skills.
-
Ability to work independently and as part of a team.
-
Strong attention to detail
-
Strong organizational and project management skills.
Physical Job Requirements
The 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 & Compensation
Medtronic 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 Medtronic
We 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 here
