Regulatory Affairs Specialist - International

Medtronic
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REGULATORY AFFAIRS SPECIALIST - INTERNATIONAL

Respiratory, Gastrointestinal & Informatics (RGI) offers technologies to help with early detection and treatment of gastrointestinal diseases and cancers and focuses on reducing complications through patient monitoring.

This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career

Careers that Change Lives

The Regulatory Affairs Specialist - International will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within the domestic and International markets. In this role, you will ensure compliance with relevant FDA, MDD, ISO and other global regulations, for RGI Patient Monitoring and Respiratory Intervention products. You will support local RA to interact with regulatory authorities to assure timely new product introductions and continued product access. 

A Day in the Life

 

  • Develop US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing

  • Assist in keeping company informed of regulatory requirements in the US and EU

  • Participate on Product Development teams, providing regulatory strategy, timelines, and direction

  • Prepare US submissions and International submissions. Work with FDA to obtain product approval/clearance

  • Ensure relevant ISO and FDA Export requirements are met, as required

  • Support product shipping release.

  • Review Change Orders and assess regulatory impact of product changes on US and/or International 

  • regulatory strategy and submissions per standard procedures

  • Review labeling, training, promotional and advertising material

  • Evaluate post-market incident reports and determine MDR requirements

  • Support post market regulatory compliance activities for US/International product approvals

  • Develop and maintain regulatory affairs department procedures

  • Comply with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct

  • May travel: 10-20%

  • Or 0 years of experience with an advanced degree in regulatory affairs

Nice To Have

  • Working knowledge of global regulatory submissions
  • Degree in engineering, science, or healthcare related field
  • Regulatory Affairs Certification
  • Proven ability to lead and work effectively in cross-functional teams
  • Excellent written and verbal communications skills
  • Strong organization and time management skills

About MedtronicTogether, 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)

My Profile

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Regulatory

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

“The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.”
“Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.”
“Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.”

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.

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