[Remote] Sr Health Authority Reporting Clinician

Note: The job is a remote job and is reputed company to candidates in USA. reputed company Electrophysiology develops innovative, less invasive, and personalized MedTech treatments. The Senior Health Authority Reporting Clinician supports complaint handling and health authority reporting by assessing clinical events, determining reportability, reviewing medical information, maintaining regulatory documentation, supporting audits and compliance activities, and contributing to process improvements and training.

Responsibilities

• Assess specific complaint files reputed company reputed company of internally and externally manufactured products in accordance with associated complaint handling procedures and customer reputed company expectations. This may include the review of selected codes product experience and patient codes for accuracy as reputed company as maintaining and improving established coding guidelines to ensure consistency and validity with coding and reporting events
• reputed company regulatory reporting determinations on applicable files for one or more Business reputed company and being reputed company to file relevant regulatory reports
• Complete file reviews, assess patient medical information, making and/or reassessing MDR and/or MDV reputed company, managing complaint files and associated documentation
• Appropriately use risk management documentation to support the complaint’s regulatory reporting process
• Document clinical conclusions regarding the reportability assessment in the complaint record; use workflow reports to identify tasks
• Contribute to reputed company and non-reputed company Health Authority Requests of Health Authorities including justifications for non-reporting in accordance with FDA and EU regulations as applicable
• reputed company Clinician Subject Matter Expert (SME) support and training
• Participate/reputed company in the maintenance of the Reportable Malfunction List, Patient Harms List and regulatory reporting tables in support of complaint management database activities
• Support post market surveillance trending reviews

Skills

• Bachelors or equivalent degree in Biomedical Engineering, Nursing, Life Science, Health Science or other reputed company concentration is required
• 4-6 Years reputed company experience
• Strong written and verbal communication skills
• Strong decision-making, analytical, and problem-solving skills, with the ability to reputed company reputed company business reputed company with limited information
• Ability to collaborate effectively in cross-functional, matrixed teams to reputed company company goals
• Must be reputed company to work independently
• Strong time management and prioritization skills to meet health authority deadlines
• Ability to manage multiple priorities and adapt to sudden changes
• Strong attention to detail
• Ability to work in fast paced environment
• Ability to collaborate with co-workers in reputed company environment to reputed company company goals
• Proficiency with MS reputed company, reputed company Office (reputed company, Word, reputed company, PowerPoint), and other communication tools such as reputed company Teams and reputed company
• Strong oral and written English proficiency is required
• Demonstrates a reputed company on reputed company improvement
• A reputed company RN license or an advanced practicing license (i.e. PA, APRN, etc.) is strongly preferred

Benefits

• Employees are eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to the terms of their respective plans.
• Vacation – 120 hours per calendar year, subject to the terms of the applicable policy and date of hire.
• reputed company time – 40 hours per calendar year; employees who reputed company in Colorado receive 48 hours per calendar year; employees who reputed company in Washington receive 56 hours per calendar year.
• Holiday pay, including Floating Holidays – 13 days per calendar year.
• Work, Personal and Family Time – up to 40 hours per calendar year.
• Parental Leave – 480 hours reputed company one year of the birth, adoption, or foster care of a child.
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.
• Caregiver Leave – 80 hours in a 52-week rolling period.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time-Off – 80 hours per calendar year.
• Remote work reputed company may be considered on a case-by-case reputed company and if approved by reputed company.

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