We anticipate the application window for this opening will close on - 15 Aug 2025

 

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

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.

Medtronic’s CRDN business is at a pivotal moment, blending the established Coronary market segment with the groundbreaking Renal Denervation (RDN) Symplicity blood pressure procedure and the transformative potential of digital, data-driven technologies in the cath lab. This unique combination, united by shared customers (interventional cardiologists), cath labs, and overlapping patient populations—creates a dynamic and synergistic opportunity for growth.

The Senior Clinical Quality Specialist is responsible for assuring that clinical personnel across Medtronic are educated in, and operating within, U.S. and international regulatory requirements and standards, Medtronic standards, and facilitating continuous improvements to processes and procedures. This will be accomplished through bringing the clinical organizations into a quality systems model of operation that will bring improved business processes and ensure that quality is built into the clinical process.   

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 25% travel to enhance collaboration and ensure successful completion of projects.

 

A Day in the Life:

You will work determine and develop approaches to solutions.  Work is reviewed upon completion for adequacy in meeting objectives.  Technical solutions are provided to a wide range of difficult problems requiring imaginative, thorough, specific, and consistent with organizations objectives.  This role has frequent internal customer contacts and represents the organization in providing solutions to difficult technical issues associated with specific projects.

• Completes audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new drug application, biological licensing agreement, animal drug application or medical devices application.

• Conducts and performs investigations and ensures conformance to regulations and company standard operating procedures.

• Documents audit observations and makes recommendations for corrective and preventive action.

• May create and maintain clinical quality assurance databases, reports, and files.

• Performs quality reviews and tracks corrective and preventive actions until closure.

• May act as an advisor on clinical quality assurance protocol, amendments and/or biological licensing agreements.

• May also audit operating systems, processes and procedures.

• May support risk management operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies.

• May plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission.

• May use six-sigma methodology.

• May provide training on GCP and current regulations for those undertaking clinical studies.

• Travel up to 25% (domestic and global)

Must Have:

• Bachelor's Degree

• 4+ years of experience directly supporting clinical research within a regulated environment, or quality experience in a regulated environment (2+ years with Advanced Degree).

Nice to Have:

• Knowledge of ISO 13485 and 14155; FDA 21CFR Parts 11, 50, 54, 56, 812,814, 820;Declaration of Helsinki; ICH E6 (R3); EU Medical Device Regulation (MDR); EU General Data Protection Regulation (GDPR)

• High attention to detail and accu