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
Responsibilities may include the following and other duties may be assigned:
Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of regulatory submissions and overall regulatory information (initial, amendments, product life cycle updates)
Submissions and related processes are produced with electronic publishing tools in compliance with document management standards.
Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, project support, and providing input to systems designs.
Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
Prepares, submits, tracks, indexes and archives paper and electronic regulatory requirements in different regulatory systems and tools
Required Knowledge and Experience
Bachelor's Degree Required in Allied Sciences (Medical/ biological science/ Engineering or equivalent field)
Minimum of 1 year job experience in similar and/or related role
Regulatory or equivalent experience within medical device or pharmaceutical company, CRO, or similar organization
Background in Medical Device Regulation is a plus
Database and Regulatory Systems Management
Scientific knowledge, must be able to read and understand the technical document such as test report, raw data, drawing etc.
Computer skills (excellent knowledge of MS Office, Excel (V look), Word, affinity to computer systems (will use SAP, Calyx, RDR, etc.) and data management tools (PowerApps, PowerBI - highly preferred)
Good written and verbal English communication 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.
