Director/Manager of Regulatory Compliance Generic Medical Devices
THIS JOB HAS EXPIRED Department: Regulatory Affairs and Quality Assurance
Reports to: VP Regulatory Affairs and Quality Assurance
Position Type: Full time
Hours Per Week: Exempt
Under the direction of the VP of Regulatory Affairs and Quality Assurance, the Director/Manager of Regulatory Compliance ensures compliance of FDA Quality System Regulations and ISO 13485 standards for all quality system processes and procedures. The Director/Manager of Regulatory Compliance will ensure the analysis and timely reporting of compliance status of the Quality System. The Director/Manager of Regulatory Compliance will assist in the development and implementation of effective quality system improvement activities and will monitor the implementation of actions taken as a result of audit activities and provide management oversight and report on the progress of those actions.
Key Duties And Responsibilites:
Monitors and reviews complaint information to determine if complete and accurate information has been recorded.
Applies Clinical knowledge to timely and thorough complaint documentation.
Makes follow-up contacts with applicable parties (e.g. sales representatives, surgeons, nurses, hospital personnel, marketing personnel, etc.) in order to gather pertinent clinical or other information in order to complete complaint files.
Performs accurate and complete database searches and queries and summarizes data.
Proactively identifies areas for process improvements.
Reviews/writes product investigations reports and provides analyses, trending data, including initiating formal investigations and/or corrective action requests resulting from product complaints.
Prepares well-written Med-Watch forms for FDA reporting within prescribed timelines.
Provides support on field corrective actions and recalls including investigation, corrective action planning and effectiveness checks.
Identifies adverse MDR and Complaint trending by product.
Recognizes and alerts management to risk, legal, labeling or other product issues.
Coordinates, plans, and executes Quality System and Regulatory compliance internal audits at Generic Medical Devices, Inc. and distribution sites to assess compliance with all applicable FDA and international regulatory requirements, including ISO 13485.
Develops audit plans and schedules, approves audit schedules, and provides audit reports and quality metrics relating to observations to department managers and senior management.
Manages internal audit and corrective/preventive actions programs to maintain ISO certification and regulatory compliance.
Reports results of audits and the resulting corrective actions to management in a defined format including the categorizing of the level of Regulatory Compliance Risk. Provide compliance assessment of audit findings and prepare appropriate reports to auditees and management, and then formulate and implement proactive regulatory compliance strategies and controls.
Manages the audit activities of the Audit Pool.
Evaluates corrective action plans, evaluate, and provide consultative support to auditees relative to the implementation of regulations and their implementation.
Participates in development and implementation of QSR and MDD-ISO training programs.
Performs other duties and special projects as required.
Provides direction to the Quality Assurance and Engineering staff to assure that all development projects and manufacturing processes conform to applicable standards and documented requirements.
Minimum Requirements And Qualifications:
The requirements listed below are representative of the knowledge, skill, and or ability required for this position.
Bachelors degree in life science discipline or Biomedical Engineering or equivalent in experience of 8-10 years in the medical device industry.
Position requires knowledge of the following regulations: US FDA 21 CFR Part 820, 803, 806, Medical Device Directive, Medical Device Directive for Vigilance Reporting, and Canadian requirements for Vigilance Reporting. Medical device experience supporting complaint handling and/or MDR reporting required. Must understand the medical conditions and procedures associated with device complaints and product technologies.
Must have excellent written and oral communications skills.
Additional Preferred Qualifications:
Experience in a start-up or small company environment
Experience establishing and growing a complaint handling department
Demonstrated ability to stay abreast of changes in Quality Standards, Regulations, Quality Metrics, audit techniques and TQM practices.
||2201 34th Avenue NW |
Gig Harbor, WA 98335
|Employment Type:||Full Time|
THIS JOB HAS EXPIRED