Remote Manager Post Market Surveillance

Essential Duties And Responsibilities

This position is responsible for all the activities associated with complaint investigation, MDR/Vigilance submission, complaint data analytics, risk management and post market surveillance reports. The position will be responsible for evaluating information from a technical perspective to ensure that appropriate analysis, investigation, and failure modes have been analyzed and documented. Implement and maintain a proactive post-market surveillance system which feeds back into design. This position will be responsible for managing post market

personnel, conduct departmental training and lead the investigation of any special complaint instances which require extensive research. Responsible for managing the relationship with external analysis laboratories.

Additional Duties And Responsibilities

• Develop post market surveillance reports in conjunction with Quality, Marketing, R&D, Clinical and Regulatory.
• Manage the review, trending, analysis, and reporting of post market activities to create monthly reports. Facilitate the presentation of monthly reports to key stakeholders. Monitor metrics and drive process improvements based on performance trends.
• Evaluate current regulations, standards, and guidance impacting Post Market Surveillance systems on an ongoing basis and implement solutions to ensure continued regulatory compliance.
• Identify and escalate product issues identified in the field commensurate with risk (both potential severity and probability increases).
• Provide proper analysis of product quality, safety, and relatability issues and effective communication to management and other functions as required.
• Ensure quality customer and regulatory communications for current products.
• Support quality metrics development and monitoring, participating in regular business and quality system performance reviews.
• Ensure appropriate documentation of key data, analysis, and decisions in complaints and supporting documents and records.
• Drive identification of complaint trends and signals that can feed the CAPA process to drive continuous improvement.
• Facilitate questions and discussions from post market team members, act as team lead and point person for post market related issues.
• Responsible for processing complaints and incident (MDR, Vigilance) reports to ensure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner. Interfaces directly with internal and external customers and regulatory agencies as required.
• Apply Risk Management File and Clinical Evaluation content to Post Market Surveillance processes.
• Update SOP’s and work instructions based on changes in regulation and addition of new markets.
• Other duties as assigned.

Supervisory Responsibilities

The position will supervise Post Market Surveillance personnel.

Requirements (Education, Certificates, Licenses, Registrations, Etc.)

• Ability to read and comprehend technical drawings/ instructions, as well as a variety of company and federal regulations.
• At least 1-2 years of Supervisory or Management experience.
• Medical background preferred.
• Team player with good communication skills and customer focus.
• Effective organization, planning and time management skills.
• Demonstrated ability to perform detail-oriented work with an ability to exercise independent judgement and discretion. Able to manage multiple tasks, prioritizing activities and scheduling work to meet business needs.
• Technical writing and presentation skills.
• Bachelor’s degree in a clinical/scientific area or. A minimum of two years’ experience in a post market surveillance role in the medical device or pharmaceutical field preferred; or equivalent combination of education and experience.
• Willing to work in a team environment and contribute to group goals.
• Understanding of Quality Expectations.
• Strong interpersonal and oral skills with the ability to communicate effectively at all levels.
• Effective problem-solving skills and ability to work independently.
• Working knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR 803, 806 and 820; ISO 13485, ISO 14971, Canadian Medical Device Regulation (SOR/98-282), Japan MHLW Ordinance 169.

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