Director / Sr. Director Regulatory Compliance Generic Medical Devices
THIS JOB HAS EXPIRED General Description:
The Director / Sr. Director, Regulatory Compliance is responsible for implementing and maintaining a regulatory program that ensures compliance with the appropriate regulatory statutes in a cost effective structure that support the companys business objective. This position will also be responsible for the analysis and timely reporting of compliance status of the Quality System and 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:
- Develops, improves and maintains the companys complaint handling system to support regulatory compliance in a cost effective structure.
- Monitors and reviews complaint information to determine if complete and accurate information has been recorded.
- Applies Clinical knowledge to timely and thorough complaint documentation.
- Proactively identifies areas for process improvements and partners with management to develop effective solutions that promote the companys business objectives.
- Proactively identifies areas for process improvements.
- Gathers pertinent clinical data from applicable parties (e.g. sales representatives, surgeons, nurses, hospital personnel, marketing personnel, etc.) in order to complete complaint files.
- Performs analytical, statistical and trending analyses on complaint data to support timely management review and proactive response or corrective action.
- 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.
- Provides support to Quality Assurance as necessary.
- Participates in development and implementation of QSR and MDD-ISO training programs.
- Performs other duties and special projects as required.
- Supervises complaint handling staff.
- Provides strategic direction and oversight for regulatory processes, systems and controls.
10 travel required
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 experience equivalency. Masters Degree a plus.
- 10years experience in medical device regulatory and quality functions.
- 5 years in a supervisory role.
- 3 years of relevant clinical experience.
- Experience in a leadership role in a start-up or early stage medical device company.
- 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.
- Proven experience establishing and maintaining a complaint handling department.
- Extensive 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.
||2201 34th Avenue NW |
Gig Harbor, WA 98335
THIS JOB HAS EXPIRED