Manager, Post Market Surveillance
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading. We need to include sections only when posting has real specific content. We have content: About the company (maybe "About Inspire Medical Systems") but not "About the role". However we could treat "About Inspire Medical Systems" as "About the role"? Probably not. The instruction says use those headings as examples; we can use other headings if appropriate? It says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they expect those exact headings if content exists. We have content for Responsibilities (MAIN DUTIES/RESPONSIBILITIES), Qualifications (QUALIFICATIONS), Benefits (BENEFITS AND OTHER COMPENSATION), Pay (Salary). Also maybe "About the role" could be the POSITION SUMMARY. That seems appropriate: we can use "About the role" heading for position summary. Also "Skills" maybe not separate; we could embed skills in qualifications. We'll include sections: About the role, Responsibilities, Qualifications, Benefits, Pay. Ensure we don't include empty sections. Also we need to preserve all substantive info, not invent. Remove boilerplate like EEO etc. Also remove duplicated lines. We'll need to parse the posting.
Let's extract:
Company description: "ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve." This is company overview; maybe we can include under "About the role"? But better to include as a brief intro before sections? The instruction: do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. It didn't forbid including a company description paragraph. Could be placed as a
before sections. Not a heading. We'll include it as a
. Then "WHY JOIN OUR FAST-GROWING TEAM" includes benefits description; but we already have Benefits section later. We'll incorporate relevant parts into Benefits. "POSITION SUMMARY" content: "This position must provide leadership and subject matter expertise in global complaint handling quality system requirements and regulations. This position will manage the following complaint handling processes: complaint initiation, preliminary complaint investigation, call center and investigator staffing / management and complaint handling training. This also includes process monitoring, trending and reporting. This position will work closely with cross-functional groups to ensure proper and timely processing of complaints and other support activities. The individual for this position must be able to work well in a team environment, foster team building, proactively communicate task status, and operate with a high level of initiative, along with excellent verbal and written communication skills for effective communication with various levels of management. The individual must be comfortable working in a fast-paced and constantly changing environment." We'll put that under About the role. "MAIN DUTIES/RESPONSIBILITIES" list: we need to convert to
- . Let's extract bullet points:
- Manage the incoming complaint/product report process, the preliminary complaint investigation process and provide expertise global complaint handling requirements for finished medical devices.
- Lead a team of post market call center representatives and specialists (investigators) providing coaching, feedback and development.
- Manage staffing multiple shifts to ensure required coverage is met.
- Perform call handling and investigation activities as needed to support the team.
- Monitor and review incoming calls and documented complaints for completeness, accuracy and compliance.
- Deliver performance reporting on key quality processes and metrics to support compliance monitoring and continuous improvement initiatives.
- Perform, support, mentor, and coach team on medical device QMS requirements and best practices for achieving “best in class” performance and process throughput.
- Ensure that the quality and regulatory compliance is maintained in accordance with both Internal and external quality systems and standards.
- Recruit top candidates for post market surveillance positions and ensure new hires/contractors are properly trained.
- Manage incoming complaint and product reporting process for non-Inspire medical devices, Inspire clinical devices and non-medical software applications.
- Support medical device and vigilance reporting as requested along with returned product and complaint closure teams.
- Manage special projects along with product improvement processes at the direction of quality management.
We'll keep as list.
"QUALITY SYSTEM RESPONSIBILITIES" maybe could be part of Responsibilities or separate? It's more specific; but we could incorporate into Responsibilities as additional bullets. However we might create a separate section? The instruction prefers few substantive sections over many thin ones. Could merge into Responsibilities. We'll add those as additional bullets under Responsibilities.
"QUALIFICATIONS": we need to list Educational Requirements, Required Experience, etc. We'll format as
- maybe with subpoints? We'll just list each requirement as a bullet.
Let's extract qualifications:
Educational Requirements:
- Required Bachelor’s degree in a technical or scientific field or Bachelor’s degree in any discipline with a minimum of 8 years experience in implantable medical devices
- Preferred Bachelor’s degree in an engineering, nursing or other medical field.
- Preferred Master’s degree in a technical or scientific field.
Required Experience:
- Minimum 5 – 10 years’ experience in the medical device industry.
- Minimum 5 years’ experience in managing teams with customer facing responsibilities.
- Demonstrated team leadership skills and ability to prioritize, execute and report on projects
- Extensive knowledge on complaint handing requirements for ISO, FDA and European Medical Device Regulations/QMS Requirements (e.g. ISO 13485; 21 CFR Part 820.198, 820)
- Effective relationship management, ability to network, support and influence across the entire organization.
- Experience supporting external regulatory audits
- Strong interpersonal and communication (both verbal and written) skills.
- Ability to facilitate teams and deliver presentations.
- Strong project and time management skills
- Ability to work on multiple tasks concurrently with changing priorities
- Proficient with of MS Word, Excel, Outlook and PowerPoint
- Preferred: Experience with Class III active implantable medical devices
- Preferred: Clinical experience in nursing, sleep or other medical discipline
- Preferred: Front room experience supporting external regulatory audits
- Preferred: Advanced computer skills with Excel reporting and SQL
- Preferred: Internal auditor training or certification
We'll list as bullets.
"BENEFITS AND OTHER COMPENSATION": we need to extract benefits list:
- Multiple health insurance plan options.
- Employer contributions to Health Savings Account.
- Dental, Vision, Life and Disability benefits.
- 401k plan + employer match.
- Identity Protection.
- Flexible time off.
- Tuition Reimbursement.
- Employee Assistance program.
- All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
We'll list as bullets.
Pay: Salary $106,000—$145,000 USD. We'll put under Pay heading.
We must not include boilerplate like EEO etc. Remove that.
Now produce HTML fragment: start with a
for company description maybe. Then
About the role
position summary
. ThenResponsibilities
- ...
Qualifications
- ...
Benefits
- ...
Pay
Salary $106,000—$145,000 USD
. We should not include Schedule section as not present. Check for any duplicated lines: we have removed. Make sure not to include any placeholder like "commensurate with experience". Not present. Now craft final HTML. Be careful to escape any HTML special characters? The text includes ampersand (&) in "Health Savings Account". That's fine as is. Also "etc." fine. We'll output:Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
About the role
This position must provide leadership and subject matter expertise in global complaint handling quality system requirements and regulations. This position will manage the following complaint handling processes: complaint initiation, preliminary complaint investigation, call center and investigator staffing / management and complaint handling training. This also includes process monitoring, trending and reporting. This position will work closely with cross-functional groups to ensure proper and timely processing of complaints and other support activities. The individual for this position must be able to work well in a team environment, foster team building, proactively communicate task status, and operate with a high level of initiative, along with excellent verbal and written communication skills for effective communication with various levels of management. The individual must be comfortable working in a fast-paced and constantly changing environment.
Responsibilities
- Manage the incoming complaint/product report process, the preliminary complaint investigation process and provide expertise global complaint handling requirements for finished medical devices.
- Lead a team of post market call center representatives and specialists (investigators) providing coaching, feedback and development.
- Manage staffing multiple shifts to ensure required coverage is met.
- Perform call handling and investigation activities as needed to support the team.
- Monitor and review incoming calls and documented complaints for completeness, accuracy and compliance.
- Deliver performance reporting on key quality processes and metrics to support compliance monitoring and continuous improvement initiatives.
- Perform, support, mentor, and coach team on medical device QMS requirements and best practices for achieving “best in class” performance and process throughput.
- Ensure that the quality and regulatory compliance is maintained in accordance with both Internal and external quality systems and standards.
- Recruit top candidates for post market surveillance positions and ensure new hires/contractors are properly trained.
- Manage incoming complaint and product reporting process for non-Inspire medical devices, Inspire clinical devices and non-medical software applications.
- Support medical device and vigilance reporting as requested along with returned product and complaint closure teams.
- Manage special projects along with product improvement processes at the direction of quality management.
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation.
- Provide follow-up reporting as needed.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
- Ensure all direct reports maintain training records that comply with applicable quality system requirements.
- maybe with subpoints? We'll just list each requirement as a bullet.
Let's extract qualifications:
Educational Requirements:
- Required Bachelor’s degree in a technical or scientific field or Bachelor’s degree in any discipline with a minimum of 8 years experience in implantable medical devices
- Preferred Bachelor’s degree in an engineering, nursing or other medical field.
- Preferred Master’s degree in a technical or scientific field.
Required Experience:
- Minimum 5 – 10 years’ experience in the medical device industry.
- Minimum 5 years’ experience in managing teams with customer facing responsibilities.
- Demonstrated team leadership skills and ability to prioritize, execute and report on projects
- Extensive knowledge on complaint handing requirements for ISO, FDA and European Medical Device Regulations/QMS Requirements (e.g. ISO 13485; 21 CFR Part 820.198, 820)
- Effective relationship management, ability to network, support and influence across the entire organization.
- Experience supporting external regulatory audits
- Strong interpersonal and communication (both verbal and written) skills.
- Ability to facilitate teams and deliver presentations.
- Strong project and time management skills
- Ability to work on multiple tasks concurrently with changing priorities
- Proficient with of MS Word, Excel, Outlook and PowerPoint
- Preferred: Experience with Class III active implantable medical devices
- Preferred: Clinical experience in nursing, sleep or other medical discipline
- Preferred: Front room experience supporting external regulatory audits
- Preferred: Advanced computer skills with Excel reporting and SQL
- Preferred: Internal auditor training or certification
We'll list as bullets.
"BENEFITS AND OTHER COMPENSATION": we need to extract benefits list:
- Multiple health insurance plan options.
- Employer contributions to Health Savings Account.
- Dental, Vision, Life and Disability benefits.
- 401k plan + employer match.
- Identity Protection.
- Flexible time off.
- Tuition Reimbursement.
- Employee Assistance program.
- All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
We'll list as bullets.
Pay: Salary $106,000—$145,000 USD. We'll put under Pay heading.
We must not include boilerplate like EEO etc. Remove that.
Now produce HTML fragment: start with a