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.
Careers That Change Lives
This position is primarily responsible for providing support of activities supporting compliance to the Medical Device Regulations. The Medical Safety (MS) Specialist will support patient safety throughout the lifecycle as both an advocate for patient safety and in support of safe and effective use of assigned products and therapies.
With general supervision, the Medical Safety Specialist is primarily responsible for providing review of medical literature for Post-Market Product Surveillance. This position will continually monitor the safety and risk/benefit profile of products distributed, marketed and sold by Medtronic's Patient Monitoring and Respiratory Interventions Operating Units. You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance (PMV), Regulatory, and Clinical Affairs.
A Day In The Life
The Medical Safety Specialist will apply medical knowledge, clinical expertise, and product knowledge to support patient safety through the application of:
Medical Knowledge and Experience:
Medical Input:
General knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas.
Basic understanding of practical medical/scientific concepts.
Conduct post market literature surveillance from a variety of product data sources including clinical, post-market complaints, legal, and medical/scientific literature.
Review of literature for both branded, and competitive products (including competitive recalls/ field safety notices).
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.
Medical Safety Assessments:
Evaluate events and potential safety signals identified through literature notifying Post Market Vigilance (PMV), Quality, Clinical, and Regulatory related business unit processes.
Collaborating with other members of the team/ cross-functional teams who are authoring 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.
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:
Knowledgeable regarding 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).
Basic knowledge of relevant scientific literature associated with assigned devices/therapies.
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 Support career stream.
Adapt verbal and written communication style to situational context.
Adapt to changing priorities and work demands.
Must Have: Minimum Requirements
Bachelors degree required
Minimum of 2 years of direct patient care experience, or advanced degree with 0 years of experience
Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience
Nice To Have
Bachelor's Degree RN, RT (advanced preferred)
Certified Professional In-Patient Safety, CPPS (within 1 year of hire)
Ability to perform patient assessments
3+ years' experience in the medical device industry preferred.
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 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.
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.
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)
