Regulatory Affairs Specialist - Radiofrequency.
Regulatory Affairs Specialist - Radiofrequency.
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Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
In this role you will have the opportunity to lead global regulatory efforts for medical devices. Coordinate RF registrations support product development and ensure compliance with international RF standards. Act as a key liaison for internal teams and regulatory agencies managing documentation and assessing impact of design changes on compliance. This will be a remote position in Bogot.Responsibilities may include the following and other duties may be assigned:
Prepare obtain and maintain global RF registrations for Medtronic and our third-party radio products.
Coordinate and execute global strategies in collaboration with our Operating Units.
Support our Operating Units with any RF related queries.
Provide RF regulatory support for new products/therapies that include wireless components.
Provide impact assessment on RF compliance due to changes to existing products.
Work cross-functionally to resolve regulatory queries from regulatory agencies.
Manage and maintain technical documentation in line with local RF regulations.
Maintain project lists with status and activities for assigned projects.
Knowledge and Experience:
Bachelors Degree in Electric or (bio)medical Engineering.
1-2 years experience in (Radio) Regulatory function.A basic understanding of electrical engineering and medical device principles.
Curiosity and willingness to learn about the international RF regulatory landscape.
Strong attention to detail and a proactive growth-oriented mindset.
Excellent communication skills in English and comfort across cultures and time zones.
Experience with regulatory submissions of medical devices
An electronic engineering background including basic knowledge of electromagnetism and experience with wireless technologies
Desirable skills in automation using Microsoft cloud tools (Power Automate Power Apps Power BI flows)
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 95000 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
Required Experience:
Unclear Seniority
Employment Type
Full-Time
