Regulatory Affairs Specialist - RF
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RF REGULATORY AFFAIRS SPECIALIST
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Careers That Change Lives
The RF Regulatory Affairs Specialist is responsible for coordinating, facilitating and supporting all global submissions for radio frequency/telecom certification compliance, in order to enable marketing, sales, distribution, and operation of current and upcoming Medtronic CRHF products with radio/telecom features. This role will work with project teams, 3rd party vendors, regulatory authorities and/or in-country Regulatory Affairs partners to ensure that worldwide RF certifications are obtained and maintained for CRHF products per product launch timelines; interface with other functional groups (e.g. Radio Quality engineers, Design/System engineers) within CRHF to gather information and documents to prepare product submissions to international regulatory authorities.
A Day In The Life
- Work with cross-functional CRHF teams on telecom/radio regulatory certification efforts.
- Support departmental and cross functional process improvement teams.
- Develop and maintain telecom/radio regulatory related SOPs, tools and systems to support the submission for approval.
- Develop and maintain proficiency in worldwide telecom/radio certification requirements.
- Provide telecom/radio certification related training and guidance for engineers, scientists, and Regulatory Affairs Specialists and others as needed, to bring awareness to the radio regulatory requirements.
- Interface with international regulatory authorities on projects/products
- Assist with maintenance of Telecom/Radio Regulatory Affairs technical files to support compliance with telecom/radio certification requirements.
Must Have; Minimum Requirement
- Bachelor degree - Engineering
- 2 years medical device regulatory or product development experience
- Or 0 years medical device regulatory or product development experience with an advanced degree
Nice To Have
- Experience with telecom/radio medical devices development.
- Knowledge of EMC/ EMI regulatory requirements.
- Knowledge of international telecom/radio certification procedures, including details on submission, required exhibits, labeling and market surveillance mechanisms.
- Strong project management skills.
- Demonstrated competency with technical documentation used to support certification/regulatory submissions for standards, radio and safety testing, and or approval.
- Strong oral and written communication skills.
- Effective interpersonal skills.
- Ability to solve problems of moderate scope and complex.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) Additional Information
- Posting Date: Jan 5, 2021
- Travel: No
Er is geen minimale opleiding vereist
Voor deze functie is er geen minimale werkervaring vereist