SENIOR MEDICAL SAFETY SPECIALIST - PERIPHERAL VASCULAR HEALTH (remote within the U.S.)

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic Click Here

The Senior Medical Safety (MS) Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the lifecycle as both an advocate for patient safety and in support of the safe and effective use of products and therapies.

With general supervision, the Senior MS Specialist works on a range of medical safety activities of varying complexity in collaboration with MS team members and other functions, including Regulatory, Quality, Risk Management, Complaint Handling, Product Development, and Medical Affairs. The Senior MS Specialist primarily interacts with MS personnel, with other functions as needed to share information or gain input to support decision-making. The Senior MS Specialist may occasionally interact in a supportive role with external physicians.

The Senior MS Specialist will provide a medical review of commercial complaints and collaborate on investigations and responses to inquiries from regulatory. They will support the device surveillance program through the review and processing of device reports as required by regulatory agencies. They will collaborate with Technical Support, Complaint Handling, Quality, Device Analysis and Risk Management teams in support of risk assessments and/or escalated investigations. They will contribute to continuous improvement initiatives. As needed the Senior MS Specialist will provide ad hoc support to Medical Affairs and Clinical Research Leadership.

A Day In The Life

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 of medical specialties, diagnoses, treatments, and procedures.
• 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 have some involvement 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 event with 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 and Therapy 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 employee in the Support career stream.
• Adapt verbal and written communication style to situational context.
• Adapt to changing priorities and work demands.

• Bachelor’s degree with a minimum of 4 years of Clinical / medical safety experience

OR

• An advanced degree with a minimum of 2 years of Clinical / medical safety experience
  

Nice to Have

• Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience (e.g., RN, MD, PA, NP)
• Clinical experience in Peripheral vascular health
• Experience with patient safety in a medical device organization
• Experience managing clinical research complaints and safety events in global regulatory studies
• Combination of Licensure and Medical Affairs/Safety or Clinical Management experience
• 5+ years of experience 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 with general supervision; accountable for outcomes
• Able to develop trusted relationships and collaborate with co-workers and key functional partners
• Excellent verbal and written English communication skills
• 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
  

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)