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Sr Clinical Affairs Specialist, Respiratory Interventions

Carlsbad, CA 92008
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Sr Clinical Affairs Specialist, Respiratory Interventions


Carlsbad, California, United States

Requisition #:


Post Date:

Jul 31, 2020

Carlsbad, California

**Remote-based position onan interim basis only due to Covid19 Pandemic. Upon approval of Returnto Office site guidelines, this role requires the individual to work onsite.**

**Careers That ChangeLives**

**Impactpatient 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 monitoringdevices (e.g., pulse oximetry, capnography, invasive and non-invasiveventilation, endotracheal and tracheostomy tubes, central/remote monitoringtechnology)** . 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.


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
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 clinicalevaluation research studies.

+ Prepares and authors protocols and patient recordforms.

+ Conducts registered and non-registered clinical studiesof products that have been determined to satisfy a medical need and/oroffer a commercial potential.

+ Oversees and interpret results of clinicalinvestigations in preparation for new device.

+ Oversees and resolves operational aspects of clinicaltrials 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 trialbudgets.

+ May be responsible for clinical supply operations, siteand vendor selection.

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

+ Represents Medtronic from a clinical researchrespective within the country / region and also collects feedback fromlocal customers and authorities.

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

+ Drives local evidence dissemination awareness.

Other Responsibilities:

+ Provides subject matter expertise to ensure on-timecompletion of Clinical Evaluation Reports (CER) to substantiate the safetyand performance of assigned medical devices in order to support productlaunches or recertifications in various regions. (may require working withother internal or contract medical writers)

+ May be required to author CERs

+ Collaborate with Quality and other cross-functionalpartners to develop comprehensive risk documentation, such as: RiskManagement Plan, Product Risk Assessment, Design Failure Modes and EffectsAnalysis (FMEA), Software FMEA, Process FMEA, Risk Management Report, andPost Launch Risk Management Review

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

+ Participates in comprehensive literature searches todevelop and maintain in-depth knowledge and understanding of currentscientific literature required to support identified product lines andrelated clinical studies, staying informed about applicable clinicallandscapes and trends

+ Participates in and/or performs comprehensiveliterature searches to develop and maintain in-depth knowledge andunderstanding of current scientific literature required to supportidentified product lines and related clinical studies, stay informed aboutapplicable clinical landscapes and trends.

+ Provide clinical perspective and support to guide newproduct development and/or post-market product sustainability forengineering 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 andguidelines, as well as Medtronic policies and procedures.

**Must Haves (Minimum Requirements):**

**Tobe considered for this role, the minimum requirements must be evident on yourresume.**

+ Bachelor's degree and a minimum of 4 years ofexperience in **Respiratory Clinical/Clinical Research/ClinicalAffairs** or advanced degree and a minimum of 2 years of experiencein Respiratory Clinical/Clinical Research/Clinical Affairs

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

+ **Clinical research in the areaof Respiratory Care within the medical device industry or** **experience as a Respiratory Therapy Clinician on themedical/surgical floor or in the Intensive Care/Critical Care Unit.**

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

+ In-depth scientific and technical knowledge of, plusclinical experience with, Medtronic products and competitors productsplus the disease states they are used to treat. Advanced understandingof medical device risks/hazards and associated patient harms in thehospital 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/medicalcommunication, and writing complex medical or technical documentation in amanner that is easily understood by individuals with varying levels oftechnical and medical expertise.

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

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

+ Ability to independently set and manage multiplepriorities.

+ 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 JobRequirements**

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

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%

**Check out**
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: 2020-08-04 Expires: 2020-10-11
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Carlsbad, CA 92008

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