Senior Medical Safety Specialist

Medtronic • Minneapolis, MN

7d • Remote

About The Position

The Senior Medical Safety Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the product lifecycle for Neurovascular and Neuromodulation therapies. The Senior Medical Safety Specialist is primarily responsible for providing technical and clinical information regarding product usage and performance, specifically as it relates to patient safety. You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical. 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 10% of travel to enhance collaboration and ensure successful completion of projects.

Requirements

• 4+ years of clinical experience (2+ years with an advanced degree).
• Active healthcare license with clinical knowledge and relevant patient care experience.
• Bachelor’s degree or higher in a biologic science with preference towards healthcare or medical profession (e.g., nurse, nurse practitioner, physician assistant, or other related medical/scientific field).
• 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.
• Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

• Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications with a preference towards Neurovascular and/or Neuromodulation specialty experience.
• Excellent verbal and written English communication skills
• Good understanding of regulatory guidance from European Medicines Evaluation Agency (EMEA), Food and Drug Administration (FDA).
• Proficient in Microsoft Office applications including Microsoft Word and Excel and ability to learn new document systems/solutions.

Responsibilities

• Provides medical expertise and assessment to support patient safety throughout the lifecycle.
• Provides technical and clinical information regarding product usage and performance, specifically as it relates to patient safety.
• Collaborates with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical Affairs.
• Maintains medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas.
• Leverages medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle.
• Acquires and maintains proficient knowledge of assigned products and therapies, such as device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile (i.e. hazards and harms).
• Actively acquires and maintains knowledge of relevant scientific literature associated with assigned devices/therapies.
• Evaluates events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes.
• Authors high quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate.
• Critically assesses and escalates newly identified safety issues per business unit processes for investigation assessment and action.
• MD Designation only: MD may also need create and provide clinical information and safety reports as required by regulatory agencies including adverse events data from clinical trials and/or consumer usage, spontaneous or solicited sources, periodic and experience reports.

Benefits

• 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)
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior