Senior Medical Safety Specialist

Medtronic•Minneapolis, MN

1d•Remote

About The Position

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. The Senior Medical Safety Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the product lifecycle for Neuromodulation and Pelvic Health 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. Medtronic leads global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

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.

Nice To Haves

Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications with a preference towards cranial and/or spinal surgical 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

Competitive Salary and flexible Benefits Package
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)
Paid sick time (for temporary employees, as required under applicable state law)