HireDiversity

Irvine, CA, US

MDR SPECIALIST III-8866130117

Description

Advanced Sterilization Products (ASP), a member of Johnson & Johnson's Family of Companies, is recruiting for an MDR Specialist III at our Irvine, CA location.

Advanced Sterilization Products (ASP) a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP has offices around the world. For more information, please visit www.aspjj.com.

The MDR Specialist III is primarily responsible for the timely evaluation, assessment, customer follow-up, completion and filing of adverse events under the MDR and International reporting regulations (e.g., MDV). This individual will maintain the quality process associated with MDR and International Report handling, procedures and controls to ensure that all MDR and other reportable incidents are processed in accordance with established company procedures and worldwide regulations and standards. This individual will perform customer follow-up on complaints and document the reportability decision with respect to MDR and International Reporting requirements.

The MDR Specialist III will apply their extensive knowledge of FDA and international regulatory requirements in order to independently make FDA reporting decision for both domestic and international complaints. This individual will prepare and submit all MedWatch Reports (Initial and Supplemental) to the FDA within the required timeframes. This individual will obtain and review reports, as appropriate, for OUS regulatory agencies and bodies, including European Union (Vigilance), Canada, Australia and Japan. The MDR Specialist III will coordinate efforts with the J&J Legal Department for all complaints regarding litigation and assess patient medical records for relevancy to the complaint and to determine the seriousness of the reported event, as necessary. This individual will ensure medical review and reportability review are completed in a timely manner for complaints that may be reportable to the government. This individual will review complaint data and obtain additional information from affiliates, domestic accounts or field representatives, as required. The MDR Specialist III will review product evaluation results to assess whether the data is accurate, thorough, and appropriate as it relates to the complaint and ensure that management is made aware of all unique and /or unusual events as they relate to reportable product complaints. This individual will assess completeness of entire complaint record (including MDR data) to ensure compliance with all relevant regulations and internal policies and procedures in order to close reportable complaints. The MDR Specialist III will recognize complaint trends and potential product problems and report to management as appropriate and provide support (and training) to global locations involved in complaint handling for reportable events to ensure compliance with applicable regulations and procedures. This individual will develop customized complaint reports and gather MDR data and assist in generating departmental metrics.

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Qualifications


Bachelors Degree or Nursing Degree is required. A minimum of 2 years of experience in Infection Control and/or 5 years of Regulatory Affairs or Quality Assurance experience in a highly regulated industry is required. Experience in a medical device manufacturing environment is highly preferred. Experience as a Professional Infection Control Practitioner in a health care facility such as a hospital, is strongly desired. Certification in Infection Control (CIC) is highly desired.

Strong understanding and working knowledge of applicable domestic and international regulations (Quality System Regulation (specific to product complaint records), 21 CFR Part 820; Medical Device Reporting , 2CFR Part 803; Guidelines on Medical Devices Vigilance System, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, ISO 13485) is preferred. Experience working with customer complaints is highly preferred. Experience developing MedWatch and/or Vigilance Reports is preferred. Knowledge of sterilization and high-level disinfection is preferred. Knowledge of operating room, central processing and endoscopy suite practices, procedures and protocols is desirable. Knowledge of federal and state regulatory agencies, AAMI, OSHA, JCAHO, which impact the environments ASP serves is desirable. Clinical knowledge in surgical instrumentation (including endoscopic instruments) is desirable. Experience with Siebel software is preferred.

Strong technical writing skills are highly preferred. Experience interacting directly with customers is required. The ability to effectively present information and respond to questions from internal and external partners is required. The ability to function in a team environment and deliver on team objectives is required. Strong leadership and excellent written and verbal skills are required.

This position is based in Irvine, CA.

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Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)