Senior Regulatory Affairs Specialist

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

The Senior Radio Frequency 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 CRM products with radio/telecom features.

Responsibilities may include the following and other duties may be assigned:

• 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 CRM products per product launch timelines; interface with other functional groups (e.g. Radio Quality engineers, Design/System engineers) within CRM to gather information and documents to prepare product submissions to international regulatory authorities.
• Work with cross-functional CRM 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. 

Required knowledge and experience:

• Education Qualification should be from B.Tech / B.E background.
• Overall, 8 to 12 years of industry experience.
• Strong project management skills.
• Demonstrated competency with technical documentation used to support certification/regulatory submissions for standards, radio and safety testing, and approval. 
• Strong oral and written communication skills. 
• Effective interpersonal skills.
• Ability to solve problems of moderate scope and complexity.Nice to Have:

• Experience with telecom/radio medical devices development.
• Knowledge of international telecom/radio frequency regulatory requirements.
• Knowledge of international telecom/radio certification procedures, including details on   submission, required exhibits, labeling and market surveillance mechanisms.

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