Provision People Looking for Post-Market Surveillance Manager at Remote Full Time

Summary:

Our award-winning client in the medical device industry is seeking a Post Market Surveillance Manager to join their team.

Responsibilities:

• Complaint Handling:

– Lead, conduct and support complaint investigations for the 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 causes of non-conformances, and recommend changes or corrections.
– Manage the daily activities of the Complaint department to assist in complaint handling and documentation of investigations.
– Manage Complaint Coordinator(s) to include scheduling of priorities, monitoring status, performance reviews, and overall managerial 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); Chair weekly Complaint Review
Meetings; Participate in Quality Data Reviews, Management Review Meetings and CAPA Review Board Meetings; Analyze/evaluate data and draw conclusions based on evaluations.
– Manage 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:

– Manage team of contributors on 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 the 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.
– Implement 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 – provide coaching, training, and development of personnel in these areas.
– 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 the Medical products.
– Support Regulatory and Field Actions Committees, FDA inspections, Health Authority Inspections and other types of regulatory agency inspections/audits.
– 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.

Required Qualifications:

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.

• 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 would be a plus (e.g., CQM, ASQ, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles).
• 6+ years’ experience in a regulated Medical Device or Life Sciences industry with applied experience/knowledge in Investigations, Root Cause Analysis, Complaint Handling, Statistical Analysis, Risk Management, Design Control, Process Validation, FMEA/Risk Assessment, and ISO/QSR;
• At least 1-2 years of Supervisory or Management experience.
• 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.
• Ability to respond to common inquiries from members of the business
• Ability to effectively present information to personnel of all level employees.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to finger, handle, or feel and talk and hear. The employee frequently is required to stand, walk, sit, and reach with hands and arms. The employee is occasionally required to climb or balance and stoop, kneel, crouch or crawl. The employee may be asked to occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts and risk of electric shock. The noise level in the work environment is usually moderate.

Quality Assurance Responsibilities:

The individual must comply with the following quality system requirements including, but not limited to:

• Use only formally approved procedures, records, documents, and specifications known as “Control Documents” (e.g., device history records, data collection forms, drawings, procedures, and specifications).
• Use only properly calibrated and maintained equipment.
• Immediately bring to attention of the head of the Quality Assurance department any possible deviations from specified Standard Operating Procedures or Work Instructions he or she may notice.
• Ensure no components, parts, manufacturing materials or products will be released unless they meet all inspection and test criteria.
• Follow all Standard Operating Procedures and Work Instructions relating to the functions performed.
• Ensure all purchasing documents are completed to Work Instructions.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Relocation assistance
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday
• No weekends

Supplemental pay types:

• Bonus pay
• Signing bonus

Education:

• Bachelor’s (Required)

Experience:

• Complaints Handling: 6 years (Required)
• Post-Market Surveillance: 6 years (Required)
• Supervisory or Management: 1 year (Required)
• regulated Medical Device or Life Sciences industry: 6 years (Required)
• Adverse Event, Vigilance Reporting & Field Actions: 2 years (Required)

Work Location: Remote