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Renal Support Specialist in Deerfield, IL at Integrated Resources, Inc

Date Posted: 2/12/2019

Job Snapshot

Job Description


Job Description:

The NEPHROLOGY NURSE CONTRACTOR will provide clinical expertise across the Renal Therapies: Peritoneal Dialysis (PD) and Hemodialysis (HD) product lines via development and review of various documents describing the clinical use of the products and the benefit and risk of the products. As a healthcare company *** is required to develop and submit various regulatory and safety documents to regulators around the world. This position will create and/or review various documents such as annual reports for our Renal products, risk management plans, and changes to documents related to manufacturing and design changes. This person will work with cross functional teams globally; including individuals within Clinical, Medical, Quality, Regulatory and Patient Safety departments. This person will report directly to the Medical Affairs Chronic Lead. This position will require approximately 40 hours per week.

Essential Duties and Responsibilities:
1. Develop/review documents to include but not limited to Clinical Evaluation Reports (CER), Post Market Studies (PMS), Post Market Clinical Follow Up (PMCF) plans, Product Safety Update Reports (PSUR) as assigned to meet the EU Medical Device Directive (MDD) and Medical Device Regulation (MDR) requirements.
2. Responsible for the coordination, preparation and/or completion of clinical sections of renal therapy-related risk file updates, Core Company Safety Information (CCSI) or label updates, and other documents as assigned.
3. Develop and review quality related documents as they pertain to renal products.
4. Provide guidance and answers to clinical/medical questions from internal teams regarding renal products and therapies
5. Provide clinical support of complaint and adverse event analyses.
6. Assist with Regulatory Affairs by providing clinical input into the evaluation and response of Ministry of Health (MOH) queries.
7. Develop expert knowledge on all renal products.
8. Interface with other functional groups such as Medical Affairs, Regulatory Affairs, Quality, and global business units, as needed. Possess strong communication and interpersonal skills.
9. Work with team to define project deadlines and monitor project progress to ensure that documents required to support regulatory filings are submitted on time to regulatory authorities.

1. Strong management skills to:
a. respond to new demands and challenges while working effectively in ambiguous situations with changing priorities based on business needs
b. work in a multicultural and cross-functional environment to facilitate discussion and resolution of different views
2. Well-developed interpersonal skills with excellent verbal/written communication skills and teaching skills
3. Strong Microsoft Office skills required (such as Microsoft 2016 Word and Outlook, Excel 2016, and PowerPoint)
4. Familiarity with WebEx meetings preferred
5. Ability to work outside the standard 8 AM-5 PM work hours, when needed, to attend WebEx meetings with global colleagues

Education and/or Experience:
1. Registered Nurse preferably with a Bachelor's degree in Nursing
2. A minimum of three (3) year s recent clinical experience providing PD and chronic or acute HD.
3. Experience working with a Medical Device Company is preferred (permanent or contracting positions).
4. Renal product knowledge/clinical experience preferred.
5. Expertise in scientific and/or medical writing preferred.
6. Exposure to working with the FDA and/or other regulatory authorities preferred.

Interview Platform: Phone followed by onsite for local candidates/ phone followed by Video WebEx for non-local candidates