1+ months

Director, Medical Safety - Cranial and Spinal Technologies - Open to Remote Location

Work Remotely
Director, Medical Safety - Cranial and Spinal Technologies - Open to Remote Location


United States

Requisition #:


Post Date:

Sep 09, 2021

**Careers that Change Lives**

The Cranial and Spinal Technologies (CST) operating unit is looking for a passionate, conscientious medical doctor who is neurosurgical spine or spine fellowship trained to lead our medical safety team. As the Medical Director, the candidate will provide global thought leadership, medical safety expertise/guidance and will be responsible for signing off on medical safety documentation throughout the products risk management lifecycle.

The ideal candidate will have strong people leadership skills, be comfortable working with individuals across all functions and levels within the business, can translate medically relevant knowledge and experience to inform patient safety decisions, business decisions and business strategy. Additionally, the candidate will be comfortable with process documentation, medical writing, reviewing medical documentation and navigating regulatory authority documentation and interactions.

**A Day in the Life**

Responsibilities may include the following and other duties may be assigned:

+ Provides medical expertise and assessment to support patient safety throughout the product lifecycle including: product development processes, risk management, clinical trials, post-market 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 CST business product and therapy issues escalated for review in the Quality Management System.

+ Provide technical and clinical information regarding product usage and performance, specifically as it relates to patient safety and advises Product Development on safety assessments throughout product development lifecylce

+ Maintain knowledge of relevant scientific literature associated with assigned devices/therapies and maintains medical knowledge in medical specialties, diagnoses, treatments and procedures related to product and therapy areas. 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).

+ Leverage medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle.

+ Develop and execute safety strategies for the CST business.

+ In conjunction with the Medical Safety Specialists, review and provide input to issue impact assessments (IIAs), risk assessments, signal investigations, and field action assessments within the business.

+ Evaluate events and potential safety signals identified through Quality, Clinical, and Regulatory related business unit processes.Critically assess and escalate newly identified safety issues per operating unit processes for investigation assessment and action.

+ Author high quality and accurate safety assessments per operating unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate.

+ Author HCP or patient recommendation information as related to specific product communications.

+ Review and provide safety input to required deliverables (i.e. Clinical Evaluation Reports, Summary of Safety and Clinical Performance).

+ 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.

+ Collaborate with the Medical Safety team, CST Operating Unit business leaders, Quality,Research and Development, Risk Management, Quality/Post-Market VigilanceRegulatory, and Clinical senior management concerning significant patient safety issues for the OU. Interface with the regulatory agencies (domestically and internationally).

+ Attend Quarterly CST Quality management review meetings, staff meetings, and global meetings for the operating unit.

+ Collaborate with other Medical Directors and Medical Safety leaders across the enterprise to share best practices and ensure consistent patient safety oversight across CST.

+ Identify opportunities for simplification and process improvement bringing best practice solutions to the table

+ Provide medical expertise and assessment of Clinical Evaluation documentation, including sign off

+ Communicate with surgeons or health care professionals on medical safety issues

+ Manage a team of 3 or more individuals and several consultants

+ Mentor, coach and teach others in the operating unit on appropriate application of laws and standards in the areas of patient safety and safety data analyses as well as the appropriate clinical application of CST products and procedures.

+ Work within and actively promote Medtronics Core mission, corporate strategies, policies, procedures and Code of Conduct.

+ Licensed MD/DO may also need to create and provide clinical information and safety reports as required by regulatory agencies including adverse events data from clinical trials and/or consumer usage, spontaneous or solicited sources, periodic and experience reports.


**Must Have: Minimum Requirements**

+ Bachelors degree

+ Minimum of 10 years of relevant clinical experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant clinical experience with 7+ years of managerial experience

+ Medical Doctor (MD/DO) degree

+ Successful completion of post-graduate training with board certification in specialty relevant to Cranial and Spinal Therapies. (Neurosurgeon, Orthopaedic Spinal Surgeon)

+ 3+ years of patient care experience beyond residency

+ 5+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

**Nice to Have: Preferred Requirements**

+ Life sciences industry experience through any of the following: clinical trial management or participation, quality systems or regulated process controls, , globally regulated experiences (industry, practice, training)

+ Advanced degree such as MBA, MMM, MHA, MPH or degree in biostatistics and/or epidemiology and/or public health

+ Proven analytical skills working with clinical or research data or complaint 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

+ Demonstrated ability to lead collaboratively in a diverse, global, matrixed organization

+ Demonstrated ability to interprest internationally recognized standards or regulations, across devices, combination products, pharmaceuticals or HCT/P products.

+ Knowledgeable of U.S. Food and Drug Law and regulatory, device safety and/or regulatory/clinical research

+ Knowledge of: ISO 14971, FDA IDE / PMA / Complaint, MDR and ADR requirements; Epidemiology, clinical research

+ Experience interacting with FDA or other regulatory agencies

+ Experiences working in healthcare administration

**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. Lets 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)
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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2021-09-14 Expires: 2021-12-20

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Director, Medical Safety - Cranial and Spinal Technologies - Open to Remote Location


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