Regulatory Specialist

Oxford Global Resources; Overland Park (KS); On-site; USD 117,000 - 152,000; Full time

Benefits offered by this job

401(k) Retirement Savings Plan

Supplemental medical/dental/vision/dis

life and disability benefits

Paid holidays

Paid sick leave

Reasonable accommodation

Job summary

Oxford Global Resources in Overland Park, Kansas seeks aComplaint Handling Specialist to review complaint communications for regulatory compliance and reportability, ensuring timely MDR and MedWatch submissions. You will gather data from clinical staff, field reps, and labs to support investigations and product records.

You will draft communications detailing observations, investigations and corrective actions, and collaborate with engineering and QA to ensure proper coding and resolution.

Qualifications

• Experience handling complaints in medical device regulatory context.
• Experience in healthcare industry; clinical knowledge preferred.

Responsibilities

• Review complaint communications and assess regulatory compliance and reportability.
• Gather data from clinical staff, field representatives, internal employees, and laboratories for investigations.
• Document regulatory reportability decisions using investigation models.
• Draft MDRs, MedWatch and other regulatory reports for authorities.
• Apply codes to events to support product records and review with engineering and labs.
• Draft written communications detailing observations, investigations and corrective actions to physicians and customers.

Skills

Complaint handling

Regulatory knowledge

Clinical knowledge

Medical device industry

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

Hourly Rate

85-110

Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, 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 provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan. Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required. 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 [e-mail]. We will make a determination on your request for reasonable accommodation on a case-by-case basis.