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You will be updated with latest job alerts via email$ 282400 - 423600
1 Vacancy
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
The Senior Medical Director for Medical Safety (MDMS) plays a critical role as a clinician advocate and voice for the patient championing the optimization of medical device safety throughout the product lifecycle. This position supports Medtronics Cardiac Rhythm Management (CRM) and Cardiac Ablation Solutions (CAS) Operating Units as part of an existing Medical Safety team and reports to the Chief Medical Safety Officer with an operational link to Operating Unit Senior Leadership.
Leveraging deep expertise in clinical cardiac electrophysiology CRM device implantation cardiac diagnostics and other aspects of interventional cardiology the MDMS provides strategic medical oversight and input across a diverse portfolio of technologies in support of product advancement and safety. This role emphasizes collaboration across functions external engagement and leadership in all matters related to patient safety balancing risk and benefit while driving innovation.
At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Travel: Up to 10-20%
Key Responsibilities:
Medical Expertise and Oversight
Serve as a medical safety subject matter expert for CRM and CAS technologies across the product lifecycle including risk management complaint analysis vigilance reporting and clinical trial safety assessment.
Provide specialized therapeutic expertise in areas such as cardiac electrophysiology CRM device management ablation therapies and occasionally on adjacent interventional cardiac therapies (e.g. coronary and structural heart).
Offer detailed medical input into health risk assessments field safety communications labeling product development and regulatory submissions to ensure safe use of medical devices.
Collaboration and Leadership
Partner and communicate with cross-functional teams (R&D regulatory clinical quality etc.) to ensure alignment on medical safety strategies and processes.
Represent Medical Safety in leadership forums governance forums and quality management processes providing key input into safety matters and escalating patient risks as appropriate.
Work closely with Operating Unit medical leadership and other Medical Safety personnel to drive consistent best practices across the enterprise.
Safety Monitoring and Innovation
Monitor post-market safety signals assess adverse events and manage escalations of significant safety issues to senior leadership.
Provide medical input into device failure investigations and health hazard assessments to ensure patient safety.
Support the development and assessment of novel technologies and provide medical safety input for business development activities including integration of acquired technologies.
External Engagement
Liaise with regulatory bodies study investigators and healthcare professionals to address device performance and medical safety concerns.
Interact with independent committees and advisory panels to ensure transparency in safety oversight.
Support Operating Unit patient safety advisory panels and promote external collaboration.
Continuous Improvement
Periodically review medical literature clinical trial data and the competitive landscape to identify adverse or mitigating safety signals.
Contribute to the development training and mentorship of personnel within the Medical Safety function.
Must Have: Minimum Requirements
MD/DO degree (or accepted international equivalent).
Formal specialty training and certification in cardiology and clinical cardiac electrophysiology.
Either ABIM Board Certified or possess equivalent and current specialty certification from an applicable international body as applicable.
If licensed to practice medicine the candidates license must be valid unrestricted and unchallenged and the candidate must be in good standing with the licensing body.
15 years of clinical practice experience in cardiac electrophysiology CRM device management or interventional cardiology (including at least 7 years of direct patient care beyond residency/fellowship) OR 15 years of combined clinical/industry experience in therapy-relevant life sciences and healthcare settings.
10 years of managerial experience in a medical capacity (e.g. departmental leadership).
Nice to Have
Past experience within a medical device or other life sciences company in one of the following functions: medical safety medical affairs clinical R&D quality or regulatory.
Previous experience as a proctor or advisor for a medical device company in matters of device development clinical implementation safety etc.
Advanced degree in addition to an MD (or internationally recognized equivalent) e.g. MPH MBA etc.
International experience (e.g. medical practice or industry role outside the U.S. with commensurate knowledge of workflow and treatment paradigm differences across diverse geographies).
Knowledge of patient safety quality clinical research strategic planning health biostatistics and regulatory concepts.
Prior experience as a clinical investigator in a medical device clinical research study
Knowledge of Good Clinical Practice (GCP).
Experience applying principles of safety risk management.
General working knowledge of applicable global medical device regulations including FDA CFR 21 EU MDR ISO 14971 ISO 14155 and ISO 13485.
Experience interacting with FDA or other global regulatory agencies and/or Notified Bodies.
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.
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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
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 95000 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 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 religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Director
Full-Time