Principal Medical Safety Specialist

Medtronic•Minneapolis, MN

11d•Remote

About The Position

The Medical Safety team provides clinical expertise and patient safety oversight across the product lifecycle, partnering with Research & Development, Quality, Regulatory Affairs, Clinical, Risk Management, and Post-Market Vigilance teams. The Cardiac Rhythm Management Medical Safety team evaluates product performance, safety signals, adverse events, and emerging risks to support evidence-based decision-making and help ensure the safety and effectiveness of cardiac rhythm technologies. 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 up to 10% of travel to enhance collaboration and ensure successful completion of projects. As a Principal Medical Safety Specialist, Cardiac Rhythm Management, you will provide clinical and technical expertise to support patient safety activities across Cardiac Implantable Electronic Device (CIED) therapies and products. You will evaluate safety information, assess potential risks, support post-market surveillance activities, and collaborate with cross-functional partners to inform safety-related decisions throughout the product lifecycle.

Requirements

Bachelor's degree in Nursing or healthcare-related field and active healthcare professional licensure.
Minimum of 7 years of Cardiac Implantable Electronic Device (CIED) management experience OR advanced degree and 5+ years of related experience.
Experience in Medical Safety, Medical Affairs, Clinical Management, or related clinical healthcare functions.
Knowledge of CIED therapy management, device programming, remote monitoring, cardiac rhythm interpretation, and associated cardiac disease states.
Experience evaluating clinical, safety, or post-market data to support risk-based decision-making.

Nice To Haves

Experience with Medtronic programmer platforms, including SmartSync, CareLink 2090, or CareLink Encore.
International Board of Heart Rhythm Examiners (IBHRE) certification.
Medical device industry experience.
Knowledge of Food and Drug Administration (FDA), European Medicines Agency (EMA), or other medical device regulatory requirements.
Experience with statistical analysis, safety analytics, Microsoft Word, Excel, or related systems.

Responsibilities

Evaluate safety events, adverse event trends, and potential safety signals identified through Quality, Clinical, and Regulatory processes.
Conduct medical safety assessments using complaint data, scientific literature, registries, and post-market surveillance information.
Apply Cardiac Implantable Electronic Device (CIED) expertise to support patient safety evaluations and product lifecycle decision-making.
Respond to safety-related inquiries from internal stakeholders, healthcare professionals, and regulatory agencies.
Collaborate with Medical Safety, Clinical, Regulatory Affairs, Risk Management, and Quality teams to assess and address emerging safety concerns.
Maintain expertise in assigned therapies, products, scientific literature, regulatory requirements, and industry standards.
Provide evidence-based medical input to support safety reviews, risk assessments, and regulatory reporting activities.
Lead or support initiatives that improve safety practices, business processes, and cross-functional decision-making.