Quality/Regulatory Representative Needed:
Sr. Post Market Regulatory Affairs Specialist
Department: Regulatory Affairs
Reports to: Regulatory Affairs Manager
The Post Market RA Specialist III will lead the development, governance and integration of Customer Complaints, Medical Device reporting and Adverse Event Reporting, Corrections and Removals (Recall) and Proactive Post Market Surveillance processes for Apyx Medical products and ensure effective execution into the Quality Management System (QMS). This position is responsible for initiating and supporting quality systems activities in all aspects of the business, including identification and implementation of continuous process improvement activities. Maintain oversight, tracking, and escalation for Post Market Process and take action to ensure processes are maintained per company policies and industry standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Complaint Handling:
- Lead, conduct and support complaint investigations for Apyx Medical through close collaboration with Research and Development, Manufacturing, Sales and Marketing and other departments; Accountable for accuracy and quality of investigations; Assure that medical device incidents/complaints are documented, reviewed, investigated, trended, and reported in accordance with current procedures.
- Lead and perform complex investigations, coordinate and support Failure Investigations and lead projects related to complaint handling.
- Improve product performance of fielded devices via Customer Defect Tracking and Resolution. Improve overall customer experience.
- Investigate and perform Risk Assessments of complaints through the Corrective and Preventative Action process, determine root cause of non-conformances, and recommend changes or corrections.
- Lead the daily activities of the Complaint Handling process and ensure adequate and timely conduct and documentation of investigations.
- Lead operational processes to include scheduling of priorities, monitoring status, performance reviews and overall support.
- Work closely with the RA Manager to coordinate scheduling of priorities, monitoring status, performance reviews and overall support.
- Coordinate flow of returned product for proper investigation; communicate as needed with OEM customers, distributors and doctors/nurses at user facilities.
- Adverse Event, Vigilance Reporting & Field Actions:
- Complete and maintain incident reports, including submission of Medical Device Reports (MDR) and Vigilance Reports when necessary.
- Perform periodic trending and reporting of Medical Incidents (monthly, quarterly, annual summaries, as required); provide information for the weekly Complaint Review Meetings; Participate in Quality Data Reviews, Analyze/evaluate data and draw conclusions based on evaluations.
- Lead the execution of field actions to assure timeliness to include project management, development of customer communication, reporting to the appropriate regulatory agencies, tracking field action effectiveness, and agency status reports.
- Respond to agency inquiries related to field actions and/or adverse events.
- Post Market Surveillance:
- Lead post market surveillance activities. This includes the investigation of product malfunctions, product design and/or labeling problems, as well as customer dissatisfaction issues, and the regular monitoring and reporting of post market status and metrics.
- Monitor metrics and drive process improvements based on performance trends.
- Perform trending and analysis as well as Post Market Surveillance activities including compiling reports for Apyx Medical products.
- Evaluate information from a technical perspective to ensure that appropriate analysis, investigation and failure modes have been analyzed and documented; Use data driven approaches to evaluate product performance and conformance.
- Support and maintain a proactive post market surveillance system that serves as a closed feedback loop into design.
- Process Improvement:
- Lead through assessment of existing Complaint Handling, Field Actions, CAPA, Medical Device reporting and Risk Assessment process gaps, create interim and future state process solutions and monitor implementation for compliance to applicable Regulatory Agency regulations.
- Work with a cross-functional team to implement robust solutions for process/device non-conformances; Monitor complaint rates and initiate improvements where required; Contribute to Feeder System metrics reviews; Support improvement initiatives; Participate directly or indirectly on project teams to develop, consolidate and/or improve complaint vigilance and related/interfacing processes and metrics.
- Lead process improvements related to complaint/adverse events by collaborating across departments; Use technical and product knowledge for accurate feedback for current product enhancements and future product development, and for escalation/awareness of issues; Liaise with R&D and New Product Introduction teams to ensure new product readiness for complaint vigilance quality process support and other functions; Support other related continuous improvement initiatives.
- Collaboration & Integration:
- Provide guidance and expertise to business partners for the interpretation, implementation, and execution of requirements related to product complaint investigations, adverse event determination and vigilance reporting, field actions and post market surveillance.
- Build working relationships with cross functional teams including Development, Supply Chain, Manufacturing Operations, Commercial Operations, Quality Assurance, Clinical Education and Marketing to ensure process solutions are compliant, efficient and adaptable to the business.
- Lead new business projects (external manufacturers, distributed products) to ensure compliant and effective data / knowledge transfer.
- Present to senior management complaint investigation and post market outcomes and interact with Device Experts/Product Quality Owners/Product Quality Integrators to recommend improvements and improve overall risk profile of Apyx Medical products.
- Support Regulatory and Field Actions Committees, FDA inspections, Health Authority Inspections and other types of regulatory agency inspections/audits.
- Lead to ensure integration of Post Market Process into all facets of the QMS including management controls, Corrective and Preventive Actions, and Risk Management.
- Other Duties as assigned.
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities in the area of physical demands and work environment.
- EDUCATION & CERTIFICATIONS: Bachelor’s Degree (BA) from a four-year College or University in a technical, engineering and/or scientific discipline; Masters or terminal science degree preferred. Professional designations are not required but training and certificates in quality or regulatory affairs desirable (e.g. RAC, CQM, ASQ, CQE, CQA, CLIA, Six Sigma, Lean Principles).
- EXPERIENCE: 5+ years’ experience in Post Market QA/RA within the regulated Medical Device or Life Sciences industry. Specific experience required:
- Independently conducting/leading Complaint Investigations, Complaint Handling operations, Adverse Event/Malfunction Reporting, Trending, Recalls, Post Market Surveillance, Statistical Analysis, Risk Management and knowledge and application of International Regulations (e.g. US, Canada, EU, Brazil, Australia, Japan) and ISO/QSR.
- Experience discussing and handling clinical issues with patients, physicians, medical/surgical personnel and a strong knowledge of medical & clinical terminology to support these efforts.
- ATTRIBUTES & CRITICAL COMPETENCIES
- Demonstrated ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
- Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs.
- Able to present to multiple levels and departments within the organization; Strong interdependent partnering skills, interpersonal communication, influencing skills without direct line authority.
- Able to support change initiatives, develop strong effective relationships with key resources and decision makers.
- Demonstrated knowledge and expertise of post market surveillance, field actions, and complaint vigilance global regulatory requirements.
- Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations
- Able to lead an organization through continuous improvement and change; Competency in understanding system functionality in relation to process requirements.
- Able to maintain up-to-date knowledge and ensure proactive compliance to FDA & EU regulations and other applicable worldwide standards and requirements specifically as related to medical device industry and quality system regulations.
EMPLOYMENT WITH APYX MEDICAL
All employment with Apyx Medical is considered employment-at-will. Employment-at-will means that either party can sever the employment at any time for any reason. Additionally, the responsibilities and functions outlined in the description may be changed or modified at any time by Apyx Medical in response to its changing needs and at its sole and absolute discretion.
Join the team where we offer a rewarding work experience, compensation and benefits package. Salary is commensurate with professional experience. For immediate consideration, please forward your resume, along with salary requirements, to: Asanka Abeyratne, Apyx Medical Corporation, 5115 Ulmerton Road, Clearwater, FL 33760-4004 or e-mail HR@apyxmedical.com.
Complaints, Medical Device Reporting (MDRs), Adverse Event’s (AEs), Data Analysis, Post Market Surveillance , Product Investigations , Date Trending, Lab investigations, Field Actions, Recalls, Advisory
APPLYING FOR EMPLOYMENT
If you are interested in becoming a member of the Apyx Medical team, you may download our Employment Application PDF, fill it out, and send it along with your resume using any of the following methods:
EMAIL OUR HUMAN
MAIL A HARD COPY
c/o Apyx Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760-4004