FDA Product Owner

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements (or Qualifications, Skills), Benefits, Pay, Schedule. Only include sections if posting has real specific content. We need to parse the job posting. First, there is an introductory paragraph about GeneDx. That could be "About the role"? Actually "Summary" is a description of role. So we can put that under About the role. We need headings

for each section. We need to use

• for any list of duties/requirements/benefits, and

  for prose. We must not repeat job title as heading. No Job ID. We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. We must preserve all substantive information. We need to include sections only when posting has real specific content. Let's extract content: - About the role: The summary paragraph: "This role supports the development and lifecycle management of GeneDx's in vitro diagnostic (IVD) products. Unlike our other Product Owners, this individual will not own a single platform. Rather, they will own a cross-functional development process spanning multiple platforms, teams, and stages of the product lifecycle. Positioned at the intersection of Regulatory, Quality, Product, and Development, this role translates regulatory and quality-system input into actionable engineering and development work, tracks that work to completion, and identifies and escalates gaps, dependencies, and risks before they affect the program. This is not a regulatory subject-matter-expert role; Regulatory and Quality retain ownership of interpretation. It does, however, require substantial technical proficiency, including direct work in Jira and our QMS tool, authorship and review of documentation for accuracy, and a working understanding of design controls from end to end." That's substantive. - Responsibilities: List of bullet points under "Job Responsibilities". They are sentences each starting with a verb. We'll turn each into

• . List: Liaise between Regulatory, Quality, and Product/Development on initiatives with regulatory or quality-system impact Assess impact when engineering work touches requirements, design controls, risk management, V&V, design transfer, labeling, or submission documentation, and track to resolution Own the product-level requirements traceability matrix, keeping it complete and audit-ready Translate product-level requirements into Jira epics/stories for engineering execution Facilitate risk management activities with Quality, keeping the Risk Management File traceable to requirements and design outputs Coordinate technical documentation, including design control records, test protocols/reports, and labeling/IFU inputs Lead design transfer from test/dry-lab to wet lab, setting testing/risk levels and driving toward sign-off Serve as technical point of contact with Procurement and Quality on supplier qualification Maintain organized documentation across QMS tools, Jira, and Confluence Set the standard for consistent QMS tool usage across Product Owners Coordinate with the clinical lab on investigations alongside the relevant platform Product Owner Report status and risk to senior leadership Also "People Manager No" maybe indicates not a people manager? Actually "People Manager No". That seems like a field indicating not a people manager. Could be considered metadata; we might drop as it's not substantive? It says "People Manager No". Might be considered a flag; but we can ignore as it's not a duty. We'll drop. - Education, Experience, and Skills: This is a list of qualifications. We'll put under Requirements or Qualifications. The content includes: Bachelor's degree required; advanced degree (MBA, MPH, MS) or clinical training is a plus 6+ years of experience in lab operations and lab report writing processes and systems 6+ years of product management experience, including 2+ years in lab enterprise or clinician-facing tools and applications Demonstrated IVD/medical device design and development experience — requirements, design inputs/outputs, V&V, design reviews Familiarity with ISO 13485 and the FDA QMSR Experience supporting development activities that inform regulatory submissions Software background; familiarity with SDLC concepts (e.g., IEC 62304) Experience with Jira and Confluence; willingness to learn a QMS tool (e.g., Ketryx) Experience building or maintaining a requirements traceability matrix Strong cross-functional communication, including presenting to senior leadership Product Owner, Agile, or Scrum Master experience Experience supporting an FDA premarket submission (510(k), PMA, or De Novo) CLIA-regulated laboratory experience Cybersecurity documentation experience for medical device submissions Certificates, Licenses, Registrations None We need to decide section heading: Could be "Requirements" or "Qualifications". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can combine Requirements and Qualifications maybe. But we need to avoid thin sections. We have a lot of content; we can put under "Requirements". Or we could split into "Qualifications" and "Skills". But we have both education/experience and skills. Might be better to have "Qualifications" for education/experience and "Skills" for technical skills. However the instruction says prefer a few substantive sections over many thin ones. So maybe combine into one "Requirements" section covering all. We'll output

  Requirements

  then a
  with each bullet as
  • . Ensure we keep all details. - Work Environment: This includes hybrid position, office location, remote work, etc. This could be under "Benefits"? Actually benefits section is separate. Work environment could be considered part of "About the role" or maybe a separate section like "Work Environment". But the allowed headings list does not include Work Environment. So we need to fold that into existing sections if possible. Could be part of "About the role" or maybe "Benefits"? Not exactly benefits. The instruction says include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. The allowed headings are: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we must map content to those headings. Work environment could go under "About the role" as additional prose. Or we could create a "Benefits" section if there are benefits described later. There is a paragraph about culture and benefits: "At GeneDx, we believe in taking care of our people. We provide competitive compensation and benefits that reflect local market practices and legal requirements in each country where we operate, helping employees thrive both professionally and personally." That's vague; not specific benefits. There's also "We provide competitive compensation and benefits". Not specific. There's also "All privacy policy information can be found here." That's boilerplate. There's also EEO statement etc. Those we must remove. Thus we may not have a specific Benefits section with concrete details (like health insurance, 401k, etc). So we should not create a Benefits section. Pay: There's a line: "Pay Transparency, Budgeted Range $140,000—$155,000 USD". That's specific pay range. So we should include a Pay section with that info. Schedule: There's mention: "Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs." That's somewhat generic but still specific about schedule being flexible. It's not placeholder like "TBD". It says schedule will be established with leader. That's substantive enough? It's not a specific schedule but it's info. The instruction says never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD"). This is not exactly those; it's saying schedule will be established with leader. That's somewhat vague but not placeholder. I'd consider it substantive enough to include a Schedule section. We also have hybrid work details under Work Environment; we could incorporate that into Schedule or About the role. Since we already have Schedule section, we could mention hybrid work there? But schedule section is about work schedule/hours. Hybrid work is about location. Could be part of About the role. We'll keep About the role to include the summary and maybe also mention hybrid work? But we already used summary for About the role. We could add a paragraph about work environment under About the role as additional prose. That's okay. Thus sections: - About the role: includes the summary paragraph plus maybe work environment description (hybrid, office location, remote, physical demands?). Physical demands also could be included there. But we might keep it concise. Better to keep About the role as the summary only; we can add a short paragraph about work environment after the summary as part of About the role (still prose). That's fine. - Responsibilities: list. - Requirements: list of qualifications/experience/skills. - Pay: the pay range. - Schedule: the schedule statement. We must not include Benefits section because no specific benefits. We must not include Qualifications or Skills separate if we combined into Requirements. Now we need to output only HTML fragment, no /, no markdown. We'll produce:

    About the role

    ...summary...

    This is a hybrid position requiring both in-office and remote work. The employee will work from our office location in Gaithersburg, MD and remotely from a home office or other suitable location with reliable high-speed internet access. In-office work is performed in a professional office setting with standard lighting, temperature control, and low to moderate noise levels. Remote work is performed in a climate-controlled environment. Standard office equipment including computer, phone, and video conferencing tools are used in both settings. Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs.

    Physical demands: This is a sedentary role requiring prolonged periods of sitting while working at a computer. Physical demands include: Sitting for extended periods (up to 8 hours per day) Repetitive use of hands and fingers for typing and mouse operation Visual acuity for reading computer screens and documents Ability to communicate effectively via phone and video calls Occasional lifting of up to 10 pounds (office supplies, equipment) Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

    But note we moved schedule sentence to About the role; we still need a Schedule section? Actually we placed schedule sentence in About the role. If we do that, we may not need a separate Schedule section. However the schedule sentence is about standard work schedule and hours; we could keep it there. The instruction says prefer a few substantive sections over many thin ones. So we could omit Schedule section and include schedule info in About the role. That seems okay. But we still have Pay section separate. Thus sections: About the role, Responsibilities, Requirements, Pay. Check if we need to include any other info like "People Manager No". That's minor metadata; we can drop. Now ensure we preserve all substantive information: Did we lose any? Let's list all substantive pieces from posting: - Intro about GeneDx (company description) - we may drop as it's not role-specific? It's generic company overview. Could be considered boilerplate? It's about the company, not the role. The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. The company description is substantive about the company but not about the role. However it's likely considered part of the job posting context. Should we keep it? The instruction says "Preserve ALL substantive information; do NOT invent or summarize away detail." It doesn't restrict to role-only. So we should keep the company description as part of About the role maybe. But the About the role heading is for role description; we could include the company description as a preceding paragraph before the role summary. However the instruction says "use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't forbid having extra paragraphs outside those sections? It says output