We anticipate the application window for this opening will close on - 16 Nov 2026
About the RoleThe 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 RequirementsTo be considered for this role, please ensure the minimum requirements are evident on your resume.
- 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 background with the ability to understand complex disease states and different treatment outcomes and complications.
- Versatile learner, able to quickly and effectively integrate new information and skills.
- Solid critical thinking and problem-solving skills.
- High attention to detail and accuracy, able to work independently, accountable for outcomes.
- Able to develop trusted relationships and collaborate with co-workers and key functional partners.
- Good understanding of regulatory guidance from the European Medicines Evaluation Agency (EMEA), and the Food and Drug Administration (FDA).
- Proficient in Microsoft Office applications including Microsoft Word and Excel and ability to learn new document systems/solutions.
Physical Job RequirementsThe 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & CompensationMiniMed offers a competitive salary and flexible benefits packageAt MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.
Salary ranges for U.S (excl. PR) locations (USD):$87,000.00 - $149,000.00
For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,00.00-$165,000.00 USD.
Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
This position is eligible for a short-term incentive called the Short Term Incentive (STI).
At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.
For further details about our comprehensive benefits, we encourage you to visit the link below.
MiniMed Benefits Overview
