We currently have a great opportunity available for a Manager, Post Market Surveillance. The Post Market Surveillance Manager follows Regulatory and Quality Systems requirements to ensure compliance in surveillance activities. This role works with a team of associates responsible for Complaint Handling and Medical Device Reporting (MDR) in the Quality Assurance department, facilitates gathering of post-market surveillance data, participates in evaluation of the data, and initiation of action(s) as required. The Post Market Surveillance Manager works collaboratively with various Sysmex business units, and business functions in the areas of Technical Assistance Center, Customer Care, Operations, Customer Service, and Marketing, etc. to support and/or conduct Field Corrective Actions (FCA) and product recalls. Responsible point of contact for regulatory agencies for MDR inquiries. 

 Essential Duties and Responsibilities:

1. Support the development and review of potential Medical Device Reports (pMDR), provide medical consultation and written opinion of risk as needed.
2. Prepare Health Hazard Evaluations for FDA and/or Health Canada reportable events, as applicable. Includes clinical assessment of harm or potential harm and impact to patient test results or user.
3. Expand and/or revise medical decision trees to meet requirements set forth by FDA and/or Health Canada for evaluation. Provide medical opinion for common hematology, urinalysis, and coagulation test results related to cut-off values based on standards of care to enable the Product Complaint Specialist team to determine risk.
4. Summarize and assemble required records for recalls and field correction files. Collect post-market customer feedback and safety information. Develop product recall / FCA strategies and user communications.
5. Author and submit regulatory reports and correspondence. Respond to Regulatory Agency inquiries.
6. Evaluates current regulations, standards and guidance affecting complaint and MDR procedures and updates written procedures for continued compliance with domestic and international regulatory requirements.
7. Ensures quality metrics in areas of responsibility are achieved and systemic trends are addressed. Tracks and analyzes key success indicators, trending and reporting metrics that effectively measure and communicate quality performance and team productivity to established objectives.
8. Participates in quality system activities and supports internal and external audits. Maintains audit-ready complaint, recall / FCA and Post Market Surveillance files.
9. Manages and supports the day to day activities of the Complaint and Medical Device reporting functions to maintain compliance with all related regulations and standards
10. Other duties as assigned.

Percentage of Travel: Up to 5%

Physical Demands: Light physical effort.  Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work.  May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions. 

• Bachelor’s degree or Associate’s degree in nursing required. +5 years of previous experience in clinical risk management required. 
• Registered Nurse (R.N.) required.
• Experience in Quality Assurance and Regulatory Affairs in the medical device industry with attention to post-market surveillance, complaint handling and field corrective actions preferred.
• Ability to effectively communicate orally and in written communications with a broad spectrum of people having varying backgrounds, education, and experience.
• Proficient in personal computer operations and Microsoft applications (Word, Excel, Access, etc.).
• Knowledge of SAP and TrackWise are a plus.
• Knowledge of industry practices, techniques, standards, and applicable FDA, ISO and international regulations regarding quality systems (21CFR 820, 822, 803, 806, 809 and CMDR sections 59-65)
• Skill in responding to common inquiries from internal customers, regulatory agencies and members of management.
• Analyzing problems, identifying alternative solutions, projecting consequences of proposed actions and implementing recommendations in support of project completion and goals.
• Training and coaching others.

Sysmex’s COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by your start date.  To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual’s ability to provide proof of current vaccination status.  Sysmex makes reasonable accommodations when needed for medical or religious reasons.  However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job.

Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.