Regulatory Specialist — Medical Devices & MDR Expert

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

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.