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Sr Clinical Affairs Specialist, Respiratory Interventions

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Clinical
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20000BDU Requisition #

Location:  Carlsbad, California

 

Remote-based position on an interim basis only due to Covid19 Pandemic.  Upon approval of ‘Return to Office” site guidelines, this role requires the individual to work onsite.

 

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 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., 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 and input for Clinical Evaluation Reports (CER), 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 safety and beyond. 

 
MITG

The Minimally Invasive Therapies Group (MITG) strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

 

Within MITG, the RESPIRATORY, GASTROINTESTINAL & INFORMATICS  (RGI)  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.

  • Oversees, designs, plans and develops clinical evaluation research studies.
  • Prepares and authors protocols and patient record forms.
  • Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
  • Oversees and interpret results of clinical investigations in preparation for new device.
  • 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.
  • May be responsible for clinical supply operations, site and vendor selection.
  • 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:
  • Provides subject matter expertise to ensure on-time completion of Clinical Evaluation Reports (CER) 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)
  • May be required to author CERs
  • 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
  • Participates in and/or performs 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, stay 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.

  • Bachelor's degree and a minimum of 4 years of experience in Respiratory Clinical/Clinical Research/Clinical Affairs or advanced degree and a minimum of 2 years of experience in Respiratory Clinical/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 Therapy Clinician on the medical/surgical floor or in the Intensive Care/Critical Care Unit.
  • 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 competitor’s 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 from a 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. Let’s 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.

 
 
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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
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