This critical position will provide senior level medical expertise in the area of Neuroscience and related clinical disciplines to ensure patient safety for the Pain Management business within Medtronic's Restorative Therapies Group (RTG).The incumbent will report directly to the Chief Medical Officer of the Restorative Therapies Group, and engage with the Pain business unit leadership team. In addition, the incumbent will work with the RTG Medical & Scientific Affairs team, Quality, Regulatory, R&D, Clinical, and across the Pain business to provide leadership for Medical Safety. The Medical Director will also serve as the Medical Safety Officer for the Pain Business.
Provide medical expertise and objective safety oversight to ensure patient safety throughout the product lifecycle across the business unit, including product development processes, risk management, clinical trials, postmarket safety surveillance, and field actions.
Provide key clinical and strategic input to issues regarding safety, and represent the function in the Product Issue Escalation Process for all relevant high-risk Pain business product and therapy issues escalated for review in the Quality Management System.
Develop and execute safety strategies for the Pain business.
Attend Quarterly Pain Quality management review meetings, staff meetings, and global meetings for the business unit.
Collaborate with other Medical Directors and Medical Safety leaders across RTG to share best practices and ensure consistent patient safety oversight across RTG.
In conjunction with the Medical Safety Specialists, review and provide input to issue impact assessment (IIAs), risk assessments, signal investigations, and field action assessments within the business.
Provide medical review and assessment of critical safety issues impacting the business unit and recommend action, as needed.
Work closely with the Medical Safety Specialists and serve as a resource for the Medical Safety Specialist, as needed, to provide input on difficult or unclear cases.
Interact with the RTG CMO, Medical Safety, Pain BU, Quality, Regulatory, and Clinical senior management concerning significant patient safety issues for the BU.
Interface with the regulatory agencies (domestically and internationally).
Mentor, coach and teach others in the business unit on appropriate application of laws and standards in the areas of patient safety and safety data analyses.
Work within and actively promote Medtronic’s Core mission, corporate strategies, policies, procedures and Code of Conduct.
BASIC QUALIFICATIONS:
Medical Doctor (MD/DO) or equivalent degree.
Successful completion of post-graduate training with board certification in specialty relevant to Pain Therapies. (Neurosurgeon, Pain Specialist e.g., Physical Medicine & Rehabilitation, Anesthesia, Neurologist).
3+ years of patient care experience beyond residency.
5 or more years of relevant clinical experience and/or safety and/or device industry experience.
Proven oral and written communication skills.
Proven analytical and critical thinking skills.
OTHER DESIRED QUALIFICATIONS:
Life sciences industry experience- knowledge of clinical trial management, quality systems, global regulatory experience.
Advanced degree in biostatistics and/or epidemiology and/or public health.
Proven analytical skills working with clinical or research data.
Knowledge of patient safety, quality, clinical research, strategic planning, health biostatistics or epidemiology.
Strong “influence management” skill set demonstrated in both the healthcare delivery and corporate environment.
Demonstrated success in effectively managing teams, executing on projects, and communicating expectations.
Strong leadership skills and ability to work collaboratively within a diverse, global, matrixed organization.
Knowledgeable of U.S. Food and Drug Law and regulatory, device safety and/or regulatory/clinical research.
Experience interacting with FDA or other regulatory agencies.
Knowledge of: ISO 14971, FDA IDE / PMA / Complaint, MDR and ADR requirements; Epidemiology, clinical research.
TRAVEL:
Domestic and international travel 20%, including weekend and evening travel as needed.
Location: Minneapolis, Minnesota
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