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Hill-Rom Clinical Evaluation Report (CER) Specialist-(REMOTE U.S.) Post Market Surveillance in Skaneateles Falls, New York

Description

The Clinical Evaluation Report (CER) Specialist will be part of a team responsible for the development, coordination, and maintenance of Hillrom’s Clinical Evaluation Reports (CERs) and CER-related regulatory compliance documents (Post-Market Surveillance Plans (PMS Plans) and Post-Market Clinical Follow-Up Plans (PMCF Plans)). S/he will drive successful execution within established budgets and timelines while ensuring consistency with regulations, quality standards, commitments, and goals.

MAIN RESPONSIBILITIES

  • Creates and manages a detailed project schedule for assigned Clinical Evaluation Reports (CERs) and Post Market Clinical Follow-Up processes to comply with global regulations.

  • Authors and coordinates CERs and CER-related documents along with PMCF activities (e.g. studies, investigations).

  • Provides CER subject matter expert (SME) support as needed by CER teams during development of new CERs and updates of existing CERs.

  • Liaises and advises other Hillrom functional units (Engineering, Marketing, Quality, Regulatory, etc.) of the relevant requirements for CERs and CER-related documents and ensure the outputs from the individual functional units meet the applicable regulatory requirements.

  • Communicates directly with Notified Bodies, Competent Authorities and other Regulatory Authorities as required.

  • Participates in internal and external regulatory audits as required.

  • Performs other duties and projects as assigned.

Qualifications

  • BS/BA in a related medical science discipline.

  • Minimum of 2 years’ experience writing Clinical Evaluation Reports (CERs) and CER-related regulatory compliance documents or of technical writing in an academic or medical device/pharmaceutical industry.

  • Ability to review and assess quality of compliance documents and technical writing.

  • Proficient in Excel, Word, Outlook, PowerPoint, & SharePoint.

  • Knowledge of EU MDR/MDD requirements specifically related to Clinical Evaluation Reports (CERs) and CER-related regulatory compliance documents (Post-Market Surveillance Plans (PMS Plans) and Post-Market Clinical Follow-Up Plans (PMCF Plans))

  • Ability to make evaluative judgments and interpret scientific literature with solid understanding of scientific/clinical research methodology.

  • Strong project planning and vendor management skills with ability to multi-task and manage multiple projects in parallel.

  • Excellent verbal and written communication skills, including technical writing.

  • Strong interpersonal skills; demonstrated success partnering with individuals to build relationships with stakeholders.

Job: Marketing

Primary Location: United States-Minnesota-St. Paul

Other Locations: United States-Indiana-Batesville, United States-New York-Skaneateles Falls

Schedule Full-time

Travel Yes, 10 % of the Time

Posting Entity Hillrom

Req ID: 21124377

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