Hill-Rom Senior Clinical Specialist in Skaneateles Falls, New York
The Senior Clinical Specialist provides clinical expertise, perspective and input to the Post Market Surveillance workflow, including aspects of Risk Management, of all Hill-Rom entities, by performing clinical evaluations of adverse events, as well as supporting the determination of complaint reportability to ensure timely reporting to regulatory agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Provides timely clinical evaluations of all potentially reportable complaints for all Hillrom entities with reports of adverse events (injury and/or death).
Determines severity of all reported adverse events, as well as likelihood of harm, and documents efficiently in the complaint management system.
Determines the causal relationship between the reported adverse event(s) with the respective medical device and assists with determining overall reportability of complaints as required to maintain timely and accurate Medical Device Reporting to regulatory agencies.
Communicates with end users as required to obtain necessary clinical information to conduct thorough investigations, as well as communicate and engage other Hillrom clinical staff and cross-functional teams as necessary.
Identifies patient and/or user risks related to clinical environment and/or medical device use/workflows; assists with identification of existing or potential mitigations and standard of care practices.
Offers clinical support through insight and perspective for review and approval of product risk documents such as Hazardous Situation List, Risk Assessment Control tables and/or Health Hazard Evaluations.
Delivers pertinent clinical information for customer response letters in relation to Post Market Surveillance, as well as clinical review and input to regulatory responses pertaining to a clinical nature.
The primary role of the Senior Clinical Specialist is to provide clinical expertise to support all areas of Post Market Surveillance and provide clinical input to medical device risk management documentation.
The Senior Clinical Specialist works independently, with various global cross-functional teams.
EDUCATION AND EXPERIENCE:
Registered Nurse with active license
Bachelor’s Degree in Nursing preferred or Associates Degree with equivalent work experience with
7 years in clinical nursing experience with preferred background in cardiac care, ICU or Surgical experience
2 years in medical device industry or related GMP environment or equivalent preferred
Desired knowledge of FDA, European regulatory or Quality System requirements.
2 years of relevant work experience in a Quality, or Regulatory role preferred.
QUALIFICATIONS AND SKILLS:
Proficient with Microsoft systems (Excel, PowerPoint and Word) required
Experience with documentation and technical writing skills, in a regulated compliance environment is preferred
Ability to communicate between various organizations and work with multi-functional teams, including senior leadership
Excellent organizational skills and ability to plan and implement resolutions to problems
- Must have active and valid nursing license
Primary Location: United States-Minnesota-St. Paul
Other Locations: United States-Indiana-Batesville, United States-New York-Skaneateles Falls, United States-Illinois-Chicago, IL
Travel Yes, 10 % of the Time
Posting Entity Hillrom
Req ID: 20124126