Senior Clinician - Post Market Surveillance

Proclinical, in support of our client, are seeking an experienced Clinical Specialist with a strong understanding of Product Safety and Risk Management techniques to join a rapidly growing Medical Device company based in Orange County, CA. The successful candidate will be responsible for performing reviews of technical investigations and the completeness of conclusions for returned product analysis for inclusion in medical device reports. Additionally, the candidate will also perform reviews of complaint reports to identify any significant issues that need escalation or expedition.

Responsibilities

• Monitor customer complaint data for product quality trends.
• Review monthly surveillance data to identify any significant triggers and providing analysis of these events to identify any safety concerns.
• Perform clinical reviews and provide input of clinically related product risk issues.
• Provide guidance to worldwide investigations of product related events reported from patients, customers, clinical account specialists, and clinical studies/registries in order to assess product relationship to reported complaint.
• Perform FMEAs, Risk Management Plans, Risk Management Reports, and Clinical Evaluation Reports.

Skills And Qualifications

• RN (Registered Nurse) license required; NP (Nurse Practitioner) or MD preferred.
• Experience in the medical device industry, ideally in clinical.
• Regulatory Affairs, Quality Assurance, and/or complaint handling experience in the Medical Device industry
• Experience interacting with regulatory bodies.
• Knowledge of statistical analysis in support of communicating trend analysis.
• Expert knowledge of medical terminology.
• Experience in scientific research.
• Strong knowledge of Microsoft Office suite.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Alex Tooulas at +442074376824 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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