FloodGate Medical
Senior Manager, Post Market Surveillance
FloodGate Medical, Tampa, Florida, us, 33646
Company OverviewOur client is an international medical device leader specializing in the design, development, and production of advanced dermal regeneration solutions utilizing proprietary biodegradable polymer technology. With regulatory approvals from TGA, FDA, CE Mark, and others, their resorbable polymer implants are improving patient outcomes and saving lives globally.
Position OverviewThe Senior Manager, Post Market Surveillance is responsible for overseeing the post-market surveillance team and activities for medical devices and medical devices distributed by the company across all jurisdictions. This role ensures compliance with regulatory requirements, monitors product performance, and manages adverse event reporting.
Key Responsibilities
Develop and implement post-market surveillance plans in accordance with regulatory requirements (e.g., FDA, EU MDR).
Manage all post-market reporting requests to ensure timely and complete delivery (e.g., PSUR, summary data for regulatory submissions, annual reports).
Streamline the PMS process and associated procedures across jurisdictions.
Monitor the analysis of data from various sources, including customer feedback, complaint reports, clinical studies, literature sources, sales & marketing meetings, regulatory reports, across all jurisdictions.
Oversee investigations into product complaints and adverse events, ensuring timely and thorough root cause analysis.
Oversee decision-making into vigilance reporting to regulatory authorities across all jurisdictions.
Prepare and submit regulatory reports, including Medical Device Reports (MDRs) and Vigilance Reports.
Collaborate with cross-functional teams, including R&D, Quality, and Regulatory Affairs, to address product issues and implement corrective actions.
Manage trend analysis and risk assessments to identify potential product issues and areas for improvement.
Maintain up-to-date knowledge of regulatory requirements and industry best practices related to post-market surveillance.
Train and mentor PMS staff on post-market surveillance processes and regulatory requirements.
Represent the company during regulatory inspections and audits related to post-market surveillance activities.
People Leadership
Assess, attract, hire, develop and engage the best diverse talent to meet current and future needs of the business. Set KPIs for individual team members as required.
Provide ongoing feedback, coaching and recognition.
Manage non-performance issues promptly and appropriately.
Align and inspire team members by communicating a clear vision for success.
Promote a culture of continuous improvement and champion change. Bring people along and align actions with corporate strategy.
Foster a culture that aligns with the company’s values. Lead with integrity, fairness, ethics, and compliance.
Understand and effectively use Performance Management and Development processes and tools to drive engagement and performance.
Provide feedback and coaching that is invested in developing people, improving outcomes, and managing relationships effectively.
Establish and communicate clear goals and roles, commitment, inclusion, and collaboration.
Safety & Quality
Adhere to workplace health and safety laws, policies, and procedures.
Report any hazards, incidents, injuries or ‘near misses’ to the designated Safety representative.
Participate in consultation and training on safety issues in your work area as required.
Comply with all company quality standards and procedures.
Operate within the requirements of the quality system and ensure responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality processes.
Ensure all documentation is reviewed, current and quality system compliant.
Other Responsibilities
Ensure collaborative relationships with internal team members and external stakeholders.
The company may require you to undertake additional responsibilities or work in other areas to those outlined in this role subject to business requirements and your skills and competencies.
Minimum Requirements
Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Life Sciences, Quality Assurance) is essential.
Advanced degree (e.g., Master’s, PhD) in a relevant field and Certification in Quality Assurance or Regulatory Affairs (e.g., ASQ, RAPS) preferred but not essential.
The ideal candidate will have extensive experience in post-market surveillance in the medical device environment, a deep understanding of regulatory requirements, and strong analytical skills.
Minimum of 7-10 years of experience in post-market surveillance or a related field within the medical device industry, preferably Class III implantable devices.
In-depth knowledge of regulatory requirements (e.g., FDA, EU MDR) and industry standards (e.g., ISO 13485, ISO 14971).
Knowledge of the design and development of medical devices.
Experience with data analysis tools and software is a plus.
Ability to acquire, query and analyze data with focus on detail.
Experience with global regulatory requirements and submissions.
Experience working within a clinical environment.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Acceptable Candidate Locations
Remote opportunity; West Coast preferred.
Compensation & Benefits Information
Compensation includes Base Salary plus Bonus
Medical, dental and vision coverage
401k with company match
Vacation
#J-18808-Ljbffr
Position OverviewThe Senior Manager, Post Market Surveillance is responsible for overseeing the post-market surveillance team and activities for medical devices and medical devices distributed by the company across all jurisdictions. This role ensures compliance with regulatory requirements, monitors product performance, and manages adverse event reporting.
Key Responsibilities
Develop and implement post-market surveillance plans in accordance with regulatory requirements (e.g., FDA, EU MDR).
Manage all post-market reporting requests to ensure timely and complete delivery (e.g., PSUR, summary data for regulatory submissions, annual reports).
Streamline the PMS process and associated procedures across jurisdictions.
Monitor the analysis of data from various sources, including customer feedback, complaint reports, clinical studies, literature sources, sales & marketing meetings, regulatory reports, across all jurisdictions.
Oversee investigations into product complaints and adverse events, ensuring timely and thorough root cause analysis.
Oversee decision-making into vigilance reporting to regulatory authorities across all jurisdictions.
Prepare and submit regulatory reports, including Medical Device Reports (MDRs) and Vigilance Reports.
Collaborate with cross-functional teams, including R&D, Quality, and Regulatory Affairs, to address product issues and implement corrective actions.
Manage trend analysis and risk assessments to identify potential product issues and areas for improvement.
Maintain up-to-date knowledge of regulatory requirements and industry best practices related to post-market surveillance.
Train and mentor PMS staff on post-market surveillance processes and regulatory requirements.
Represent the company during regulatory inspections and audits related to post-market surveillance activities.
People Leadership
Assess, attract, hire, develop and engage the best diverse talent to meet current and future needs of the business. Set KPIs for individual team members as required.
Provide ongoing feedback, coaching and recognition.
Manage non-performance issues promptly and appropriately.
Align and inspire team members by communicating a clear vision for success.
Promote a culture of continuous improvement and champion change. Bring people along and align actions with corporate strategy.
Foster a culture that aligns with the company’s values. Lead with integrity, fairness, ethics, and compliance.
Understand and effectively use Performance Management and Development processes and tools to drive engagement and performance.
Provide feedback and coaching that is invested in developing people, improving outcomes, and managing relationships effectively.
Establish and communicate clear goals and roles, commitment, inclusion, and collaboration.
Safety & Quality
Adhere to workplace health and safety laws, policies, and procedures.
Report any hazards, incidents, injuries or ‘near misses’ to the designated Safety representative.
Participate in consultation and training on safety issues in your work area as required.
Comply with all company quality standards and procedures.
Operate within the requirements of the quality system and ensure responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality processes.
Ensure all documentation is reviewed, current and quality system compliant.
Other Responsibilities
Ensure collaborative relationships with internal team members and external stakeholders.
The company may require you to undertake additional responsibilities or work in other areas to those outlined in this role subject to business requirements and your skills and competencies.
Minimum Requirements
Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Life Sciences, Quality Assurance) is essential.
Advanced degree (e.g., Master’s, PhD) in a relevant field and Certification in Quality Assurance or Regulatory Affairs (e.g., ASQ, RAPS) preferred but not essential.
The ideal candidate will have extensive experience in post-market surveillance in the medical device environment, a deep understanding of regulatory requirements, and strong analytical skills.
Minimum of 7-10 years of experience in post-market surveillance or a related field within the medical device industry, preferably Class III implantable devices.
In-depth knowledge of regulatory requirements (e.g., FDA, EU MDR) and industry standards (e.g., ISO 13485, ISO 14971).
Knowledge of the design and development of medical devices.
Experience with data analysis tools and software is a plus.
Ability to acquire, query and analyze data with focus on detail.
Experience with global regulatory requirements and submissions.
Experience working within a clinical environment.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Acceptable Candidate Locations
Remote opportunity; West Coast preferred.
Compensation & Benefits Information
Compensation includes Base Salary plus Bonus
Medical, dental and vision coverage
401k with company match
Vacation
#J-18808-Ljbffr