Supports multiple banner ads per page, from any ad serving software. Flexible banner sizes
1+ months

Principal Clinical Affairs Specialist

Medtronic
Carlsbad, CA 92008
Apply Now
Applying for this job will take you to an external site
Principal Clinical Affairs Specialist

Location:

Carlsbad, California, United States

Requisition #:

210003BC

Post Date:

Feb 15, 2021


**Careers That Change Lives**


**Impact patient outcomes. Come for a job, stay for a career.**


Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.


The Principal Clinical Affairs Specialist is a clinician with expertise in the delivery of healthcare within a hospital setting utilizing various **respiratory and patient monitoring devices (e.g., mechanical ventilation, pulse oximetry, capnography, invasive and non-invasive ventilation, endotracheal and tracheostomy tubes, central/remote monitoring technology)** . This role will be responsible for Respiratory Interventions, supporting Ventilation, Airways, and Airway Access. Although responsibilities will vary based upon the needs of the organization, primary responsibilities include providing in-depth medical/clinical input for risk management documentation, chaos testing, and input for Clinical Evaluation documents according to established procedures in order to substantiate the safety and performance of assigned medical device products. Additional responsibilities include providing direct or indirect (in collaboration with other team members) input to new product development and post-market sustaining core teams on the topics of product use/safety and beyond.


Within MEDSURG, the RESPIRATORY, PATIENT MONITORING offers a complete line of solutions that spans the continuum of care. We help with early detection and treatment of diseases, and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.


**A Day in the Life**


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


+ Provide key input into new product design as the clinical SME

+ Abilityto stress test and challenge ventilators in simulated use case scenarios leveraging clinical experience, analytic evaluation, creative troubleshooting, and creative problem-solving. Understanding all ventilator function compared to but not limited to ventilation waveform evaluations, simulated patient evaluations, test lungs, and bench testing. Analyze and generate reports for stress testing activities

+ Participate in post data processing. Experience with mechanical test lung technology such as the ASL 5000 and Michigan Instruments TTL. Experience with digital data acquisition and analysis.

+ Prepares, presentations for teams on clinical findings

+ Contributes clinical expertise on a cross functional team to identify evidence needed to demonstrate safety and performance of new and existing devices, as well as provide clinical input into various internal and external product documentation. Such as input into new product development, MDR, CDP as the clinical SME.

+ Oversees and interpret results of clinical investigations in preparation for new or existing devices.

+ Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.

+ People working within region/country may also have the responsibilities that include:

+ Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.

+ Builds and maintains optimal relationships and effective collaborations with various internal and external parties.

+ Drives local evidence dissemination awareness.


Other Responsibilities:


+ Candidates are expected to have a deep knowledge in mechanical ventilation, respiratory care, design controls, quality assurance, regulatory affairs, and data analysis.

+ Clinical expert in the design, development and creation of complex medical devices related to respiratory, critical care or general care floor products.

+ Provide clinical perspective and support to guide new product development and/or post-market sustaining engineering core teams. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input.

+ Consult on matters affecting patient/product safety, design, testing, creation of high performing products, post market support, regulatory registration and clinical audit support.

+ Advanced knowledge of assigned products and therapies including device design and function, hazards and harms, product labeling, indications for use, populations evaluated, diseases treated, mechanism of action, care pathways, and safety profiles.

+ Gather input from external sources, marketing, R D and other business stakeholders in order to ensure testing and registration activities accurately represent healthcare use scenarios.

+ Collaborate with Quality and other cross-functional partners to develop comprehensive risk documentation, such as: Risk Management Plan, Product Risk Assessment, Design Failure Modes and Effects Analysis (FMEA), Software FMEA, Process FMEA, Risk Management Report, and Post Launch Risk Management Review.

+ Provides input into the clinical strategy for post-market activities.


+ Provides subject matter expertise to ensure on-time completion of CE documents such as CER, PMCFP/R, CERs, etc, to substantiate the safety and performance of assigned medical devices in order to support product launches or recertifications in various regions. (may require working with other internal or contract medical writers)

+ Collaborate with Quality and other cross-functional partners to develop comprehensive risk documentation, such as: Risk Management Plan, Product Risk Assessment, Design Failure Modes and Effects Analysis (FMEA), Software FMEA, Process FMEA, Risk Management Report, and Post Launch Risk Management Review

+ Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented

+ Participates in comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, staying informed about applicable clinical landscapes and trends

+ Provide clinical perspective and support to guide new product development and/or post-market product sustainability for engineering core teams. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input

+ May participate in audits

+ Consistently apply applicable global regulations and guidelines, as well as Medtronic policies and procedures.


**Must Haves (Minimum Requirements):**


**To be considered for this role, the minimum requirements must be evident on your resume.**


+ Bachelors degree and a minimum of 7years of experience in **Respiratory Therapy** **(Mechanical Ventilation -Critical Care, ECMO)** **/Clinical Research/Clinical Affairs,** or advanced degree and a minimum of 5years of experience in **Respiratory Therapy (Mechanical Ventilation -Critical Care, ECMO)/Clinical Research/Clinical Affairs.**


**Nice to Have (Preferred Qualifications):**


+ **Clinical research in the area of Respiratory Care within the medical device industry or** **experience as a Respiratory Therapist or Registered Nursing in the Intensive Care/Critical Care Unit.**

+ **International critical care experience with Mechanical Ventilation.**

+ **Clinical experience with relevant types of devices and technologies (e.g., pulse oximetry, capnography, invasive and non-invasive ventilation, endotracheal and tracheostomy tubes, central/remote monitoring technology).**

+ **In-depth scientific and technical knowledge of, plus clinical experience with, Medtronic products and competitors products plus the disease states they are used to treat. Advanced understanding of medical device risks/hazards and associated patient harms in the hospital and out-of-hospital settings.**

+ **Experience in Contract Research Organization (CRO), medical device, pharmaceutical or biotechnology firm.**

+ **Experience in the conduct of clinical research/medical communication, and writing complex medical or technical documentation in a manner that is easily understood by individuals with varying levels of technical and medical expertise.**


+ **Holds an active, unencumbered license (within profession).**

+ **Excellent oral and written communication (both technical and non-technical).**

+ **Ability to independently set and manage multiple priorities.**

+ **Understands and can work within various team dynamics, including highly matrixed environments.**


**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 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. (ADA-United States of America)**


**Travel up to 10% required.**
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.

Categories

Posted: 2021-02-18 Expires: 2021-04-26
Supports multiple banner ads per page, from any ad serving software. Flexible banner sizes

Job Rated Report

Resume Writing Advice

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Principal Clinical Affairs Specialist

Medtronic
Carlsbad, CA 92008

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast