Sr. Medical Safety Specialist (Remote)

MiniMed•Northridge, CA

1d•Remote

About The Position

The Senior Medical Safety Specialist provides technical and clinical information about product use and performance, with a focus on patient safety. The role applies medical knowledge, clinical expertise, and product knowledge to support patient safety across the product lifecycle, collaborating with Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical teams. The specialist evaluates potential safety signals and events identified through business processes, authors accurate safety assessments, escalates newly identified safety concerns, and supports qualitative and quantitative assessments of post-market adverse events. The role may also obtain input from external medical and subject-matter experts, contribute recommendations for regulatory annual reports, and provide evidence-based responses or education to internal and external stakeholders, including medical personnel and regulatory agencies. The position requires knowledge of relevant medical specialties, diagnoses, treatments, procedures, supported therapies, disease states, device design and use, product labeling, and general safety profiles. The specialist applies knowledge of medical-device lifecycle processes, governing regulations, and industry practices; communicates medical information clearly; adapts to changing priorities; and may guide entry-level professionals or support-career employees. This is a remote role. The posted application window is anticipated to close November 16, 2026.

Requirements

Be a licensed healthcare professional or certified personnel with clinical knowledge and relevant patient-care experience, such as an RN, MD, PA, or NP.
Have a bachelor's degree and at least 4 years of clinical experience in Diabetes, Medical Safety/Medical Affairs; or an advanced degree and at least 2 years of experience in those areas.
Understand practical medical and scientific concepts, including relevant medical specialties, diagnoses, treatments, and procedures.
Have a basic understanding of how to search medical or scientific databases and evaluate literature.
Understand supported therapy indications, relevant disease states, product design and use, basic mechanism of action, product labeling, and general safety profile.
Understand key medical-device lifecycle processes, governing regulations, and relevant industry practices.
Be able to interpret, synthesize, write, and present medical information accurately and logically.
Be able to make competent, risk-based, timely medical safety decisions based on analysis of critical information.
Understand scientific and technical concepts and the function of medical devices.
Communicate effectively verbally and in writing and influence diverse stakeholders, including team members, functional partners, and healthcare professionals.
Have a solid medical background and the ability to understand complex disease states, treatment outcomes, and complications.
Be able to learn and integrate new information and skills quickly.
Have critical-thinking and problem-solving skills.
Demonstrate attention to detail and accuracy, work independently, and be accountable for outcomes.
Build trusted relationships and collaborate with coworkers and key functional partners.
Have a good understanding of regulatory guidance from the European Medicines Evaluation Agency (EMEA) and the Food and Drug Administration (FDA).
Be proficient in Microsoft Office applications, including Word and Excel, and able to learn new document systems or solutions.

Nice To Haves

Experience managing clinical research complaints and safety events in global regulatory studies.
A combination of licensure and Medical Affairs/Safety or Clinical Management experience.
Five or more years of experience in the medical-device industry.

Responsibilities

Provide medical safety input to internal functions and business processes across the product lifecycle.
Evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory processes.
Author accurate safety assessments using complaint data, literature, registries, and other appropriate data sources.
Critically assess and escalate suspected increases in the severity or frequency of known events, and newly identified events potentially causally related to the device.
Assist with obtaining input from external medical and subject-matter experts on safety matters.
Complete qualitative and quantitative assessments of post-market adverse events and their medical significance.
Make recommendations for inclusion in regulatory annual reports.
Provide evidence-based medical safety input, education, and responses to inquiries from internal and external stakeholders, including medical personnel, third parties, regulatory agencies, and healthcare organizations.
Collaborate with Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical functions.
Communicate medical information accurately and logically, adapting verbal and written communication to the situation.
Adapt to changing priorities and work demands.
May provide guidance and assistance to entry-level professionals or employees in the support career stream.