Sr. Medical Safety Specialist (Remote)
USA-MiniMed Distribution Corp. 1018
- Remote job
We anticipate the application window for this opening will close on - 16 Nov 2026 At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world. About the Role The Senior Medical Safety (MS) Specialist will be primarily responsible for providing technical and clinical information regarding product usage and performance, specifically as it relates to patient safety. The Senior MS Specialist will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical to help deliver against our highest quality standards. The Senior MS Specialist will apply medical knowledge, clinical expertise, and product knowledge to support patient safety through the application of Medical Knowledge and Experience Medical Input: Basic understanding of practical medical/scientific concepts. General knowledge in medical specialties, diagnoses, treatments, and procedures related to product and therapy area. Basic understanding of how to search medical/scientific databases and evaluate literature. Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle where the Medical Safety role is defined. May be involved in cross-functional assignments. Medical Safety Assessments: Evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes. Author high-quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate. Critically assess and escalate newly identified safety issues (suspected increase in severity and/or frequency of known events or new events with a causal relationship to the device) per business unit processes for investigation assessment and action. Assist with obtaining input from external medical and subject matter experts on safety matters. Complete qualitative and quantitative assessments of post market adverse events, medical significance, and recommendations for inclusion in regulatory annual reports. Safety Inquiries: Provide evidence-based medical safety input, education and/or response to safety inquiries from internal or external stakeholders (e.g., external medical personnel or other third-parties, including regulatory agencies or health care organizations). Product therapy and knowledge: Basic understanding of supported therapy indications and relevant disease states. Understands product design and use, basic mechanism of action, product labeling, and general safety profile. Business Acumen: Basic understanding of key medical device lifecycle processes. Knowledgeable of governing regulations and key industry practices related to the function. General awareness of organizational design, functional roles, and key business strategies. Aware of and contributes to the MSO function strategy success. Medical Communication and Influence: Basic ability to interpret, synthesize, write, and present medical information in an accurate and logical manner. Interacts primarily and effectively with internal peers. External interactions are less complex or problem solving in nature. May provide guidance and assistance to entry level professionals and /or employees in the support career stream. Adapt verbal and written communication style to situational context. Adapt to changing priorities and work demands. Must-Have: Minimum Requirements Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience (e.g., RN, MD, PA, NP). Bachelor's degree with a minimum of 4 years of Clinical Experience in Diabetes, Medical Safety/Medical Affairs, or an advanced degree with a minimum of 2 years of experience in Diabetes, Medical Safety/Medical Affairs. Nice to Have Experience managing clinical research complaints and safety events in global regulatory studies. Combination of Licensure and Medical Affairs/Safety or Clinical Management experience. Five or more years in the Medical Device Industry Basic ability to understand and apply practical medical and product knowledge in a competent manner for Medical Safety activities. Able to make competent, risk-based, and timely medical safety decisions based on insightful analysis of critical information; able to balance analysis with decisiveness. Able to understand scientific/technical concepts and the function of medical devices Able to effectively communicate verbally and in writing, and effectively influence diverse stakeholders (team members, functional partners, and HCPs). Solid medical #J-18808-Ljbffr USA-MiniMed Distribution Corp. 1018
$101.44k - $126.79k
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