Regulatory Affairs Specialist - Instruments

Company: On Assignment, Inc./Oxford Global Resources
Location: Stamford
Posted on: September 19, 2022

Job Description:

Summary:

Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.

Project Details:

* Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations
* Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis
* Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models
* Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transition to the appropriate regulatory authorities
* Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff
* Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers. Communications include determination/eligibility for warranty credit or unreimbursed medical payments

Job Experience:

* Prior experience within complaint or regulatory handling
* Experience in medical device or healthcare industry - clinical knowledge is preferred

Oxford is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefits@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.

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