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Regulatory Operations Specialist
hace 4 horas
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
This position is part of the Global Regulatory Operations Group within the Medtronic Clinical & Regulatory Solutions (MCRS) organization, supporting regulatory systems and processes. Primary responsibilities include assisting in the preparation, publication, quality control and delivery of regulatory submissions, as well as working with International Geography RA groups to complete product registrations, notarization, authentication and providing notification of changes. Submissions are produced with electronic publishing tools in compliance with internal and external document standards. Prepares, submits, tracks, indexes and archives electronic submissions, as well as related information including approvals, amendments, annual reports, and FDA/Regulatory Agency communications. Additional duties include developing international device product registrations, maintaining global product registrations, and developing department processes and systems. This role primarily interfaces with regulatory affairs teams, operating unit (OU) regulatory teams, regulatory operations teams, manager, and director.
Responsibilities may include the following and other duties may be assigned:
- Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training, developing and implementing plans, 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 electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
- Responsible for helping to develop and to manage international product registrations, including working with the regulatory affairs team and OUS geography specialists to respond to requests for information.
- Supports and processing of International CFG's and CFS's and International Requests.
- Manages international product registrations, including working with the regulatory team and OUS geography specialists to respond to requests for information.
- Basic understanding of global regulatory requirements and approach for researching detailed requirements.
- Responsible for participating in lean sigma/A3 DMAIC projects within the department to improve processes. This includes identifying and implementing metrics to enhance business efficiencies.
- Ensure submissions are formatted and produced with electronic publishing tools in compliance with document management standards.
- Support value stream payment processing.
Required Knowledge and Experience:
- Bachelor's degree in sciences, engineering, or field related experience.
- Advanced level of English (C1 and higher)
- Regulatory Operations experience is required
- Ability to work in a hybrid environment in Bogota, Colombia
- Intermediate knowledge of word processing, spreadsheet, database and graphics presentation applications (Microsoft Office, Adobe Acrobat, Documentum, and SharePoint).
- Organizational skills, highly detail oriented, and effective project management skills.
- Highly detailed orientated and possess strong analytical skills to evaluate complex technical information.
- Document interpretation, queries and workflow skills.
- Flexible with changing priorities and works well under pressure in a fast paced, dynamic environment.
- Self-motivated, strategic thinker, team player, strong work ethic, tactful, exercises independent judgment and sound decision-making.
- Ability to work in matrix structured organization.
Nice to have:
- Publishing experience
- Worked with US and EU companies
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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
