Senior Medical Safety Specialist

Senior Medical Safety Specialist

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Position can be remote in the United States.

The Senior Medical Safety Specialist is responsible for providing medical expertise and assessment to support patient safety throughout the product lifecycle.

The position is primarily responsible for providing technical and clinical information regarding product usage and performance, specifically as it relates to patient safety. You will collaborate with multiple functions including Research and Development, Risk Management, Quality/Post-Market Vigilance, Regulatory, and Clinical.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts.

You will apply your medical knowledge, clinical expertise, and product knowledge to support patient safety through the application of:

• Medical Input: Maintain medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas. 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 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 and Therapy Knowledge: Acquire and maintain proficient knowledge of 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). Actively acquire and maintain knowledge of relevant scientific literature associated with assigned devices/therapies.
• Business Acumen: Acquire and maintain advanced knowledge of applicable business unit policies/procedures, and relevant regulatory requirements and guidelines (e.g., ISO 14971, Application of Risk Management, ISO 13485, Quality Management Systems). Maintain an advanced understanding of key business processes involving Medical Safety (e.g., risk management, post market vigilance). Work effectively across the matrix. Develop solutions and lead opportunities to advance and improve safety practices. May lead other projects as assigned in part or in entirety that span outside of Medical Safety.
• Medical Communication and Influence: Lead and influence evidence-based medical decision making across the matrix organization. Provide strategic input and influence business strategies to optimize Medical Safety value. Interpret, analyze, and effectively communicate medical assessment across a variety of levels and audiences.
• Adapt verbal and written communication style to situational context. Adapt to changing priorities and work demands.

** There will be up to 10% travel for this position.

Minimum Requirements

4+ years of clinical experience (2+ years with an advanced degree).

Active healthcare license with clinical knowledge and relevant patient care experience. Bachelor's degree or higher in a biologic science with preference towards healthcare or medical profession (e.g., nurse, nurse practitioner, physician assistant, or other related medical/scientific field).

Nice to Have

Solid medical background with the ability to understand complex disease states and different treatment outcomes and complications with a preference towards cranial and/or spinal surgical specialty experience. 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.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The 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.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain, restore health, and extend lifewhere your unique background and perspective are valued.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$107,200.00 - $160,800.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race,