[Hiring] Principal Medical Safety Specialist @Medtronic

Role Description

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.

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.

Primary 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.

Qualifications

• 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.

Preferred Qualifications

• 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.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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. 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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package.
• Salary ranges for U.S (excl. PR) locations (USD): $130,400.00 - $195,600.00.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
• The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:
  • Health, Dental and vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance/reimbursement
  • Simple Steps (global well-being program)
• The following benefits and additional compensation are available to all regular employees:
  • Incentive plans
  • 401(k) plan plus employer contribution and match
  • Short-term disability
  • Paid time off
  • Paid holidays
  • Employee Stock Purchase Plan
  • Employee Assistance Program
  • Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
  • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)