Director, Regulatory Affairs

We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate like EEO, etc. Must not include sections with placeholder text. We need to parse the posting. Content: Intro paragraph: At Element Biosciences... mission... etc. That's about the role? Could be "About the role" or maybe "About the company". The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have About the role (intro). Then Responsibilities (Essential Functions And Responsibilities). Then Education And Experience (maybe Qualifications). Then maybe Skills? There's a list of skills/knowledge: Deep working knowledge of ISO 13485, ISO 14971, post-market requirements, labeling, change control, and applicable medical device/IVD regulatory frameworks; Exceptional regulatory judgment; Proven track record of working well cross functionally; Self-directed, proactive, embodies an enterprise mindset. Those could be Skills or Qualifications. The Education And Experience section includes education, experience, etc. Could be Qualifications. Then maybe Requirements? Might be overlapping. We need to decide. We have Physical Requirements: Ability to lift up to 20 pounds. Location: San Diego/On-site. Travel: up to 10% of the time. Job Type: Full-time. Base Compensation Pay Range $152,000 - $215,000. Benefits: stock options, discretionary annual bonus, no cost health insurance plans, 401k with company match, flexible paid time off. Also note base compensation depends on factors. We need sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections with real specific content. Let's map: - About the role: Intro paragraph describing mission, organization, role purpose. That's substantive. - Responsibilities: The list under "Essential Functions And Responsibilities". That's substantive. - Requirements: Could be physical requirements? Ability to lift up to 20 pounds, location, travel, job type? But those are more like logistics. Could be "Requirements" for the role (education/experience). However we also have Qualifications and Skills sections. Might be better to put education/experience under Qualifications, and skills under Skills. Then Requirements could be physical requirements, location, travel, job type. But the instruction says we can include sections only when posting has real specific content. We have physical requirements, location, travel, job type. That's specific. So we can make a Requirements section with those. - Qualifications: Education and Experience (minimum bachelor's degree, 12+ years, etc). That's substantive. - Skills: Deep working knowledge of ISO..., exceptional regulatory judgment, proven track record, self-directed, proactive, enterprise mindset. Also maybe "ability to advise senior executives". That's skill. - Benefits: stock options, discretionary annual bonus, no cost health insurance plans, 401k with company match, flexible paid time off. - Pay: Base compensation range $152,000 - $215,000. Also note base compensation depends on factors; but we should not include placeholder like "depends on multiple factors". That's still substantive? It's a note. Might be okay to include as part of Pay section. The instruction: never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD"). "Base compensation will depend on multiple factors, including geographic location, qualifications, and experience." That's not placeholder; it's actual info. So we can include. - Schedule: Not explicitly mentioned. There's job type full-time, travel up to 10% of time. No schedule like hours. So we should not create Schedule section because no specific schedule info. So omit. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay. Now we need to format. Use

for each heading. Then content: For prose use

. For lists use

• . We must preserve all substantive information; do not invent or summarize away detail. So we need to include all details from each section. Let's extract each. About the role: The introductory paragraph(s) before "Essential Functions And Responsibilities". Let's copy: "At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness. We are seeking an experienced Director of Regulatory Affairs to build and lead Element Biosciences' regulatory function and establish the regulatory strategies and capabilities required to support the company's continued expansion into regulated diagnostic markets. Reporting directly to the Chief Supply Chain Officer, this role will serve as Element's senior regulatory advisor and will be responsible for regulatory strategy across the company's in vitro diagnostic (IVD), next generation sequencing (NGS), and regulated life science instrumentation portfolio. The Director will establish and execute global regulatory strategies supporting product development, market authorization, commercial expansion, strategic diagnostic partnerships, and lifecycle management. This individual will work closely with executive leadership and Product, R&D, Clinical, Quality, Operations, Legal, and Commercial teams to ensure regulatory considerations are incorporated early into product and business decisions and that Element appropriately balances regulatory risk, business objectives, and speed to market. The successful candidate will bring deep IVD and medical device regulatory expertise, demonstrated experience leading complex global regulatory programs across functions and markets, strong regulatory judgment, and the ability to operate as both a strategic leader and hands-on builder in a rapidly growing organization. This role will be an onsite role based in San Diego. If you possess the following and want to make a meaningful impact, we invite you to explore this role." That's a lot. We'll put that in a

  maybe multiple paragraphs but we can keep as one

  with line breaks? Better to keep as one

  but it's long; still okay. Responsibilities: The list under "Essential Functions And Responsibilities". It's a series of sentences each starting with a verb. We'll turn each into

• . Let's extract: - Own and lead Element's global regulatory strategy for IVD, NGS, software, and regulated life science instrumentation products throughout development, commercialization, and lifecycle management - Serve as Element's senior Regulatory Affairs advisor to executive leadership and cross-functional teams, providing clear recommendations on regulatory pathways, risks, tradeoffs, and business implications - Establish regulatory strategies early in product development, including intended use, claims, classification, market pathways, evidence requirements, product configuration, and RUO-to-diagnostic considerations - Lead regulatory strategy and execution for global market authorizations, including the United States, European Union, and other priority international markets - Lead significant interactions with regulatory authorities, notified/assessment bodies, authorized representatives, and other external regulatory stakeholders - Establish regulatory strategy and responsibilities for diagnostic partnerships, co-development programs, and other collaborations involving shared or dependent product configurations - Own regulatory assessment and governance for product, software, manufacturing, supplier, labeling, and other lifecycle changes affecting marketed products - Provide regulatory leadership for post-market reporting obligations, including vigilance, adverse event/incident reporting, field actions, and emerging regulatory risks - Establish regulatory governance, decision making, and escalation mechanisms that enable timely, consistent, and well-documented regulatory decisions - Build and scale the Regulatory Affairs function, including people, external resources, governance, processes, systems, regulatory intelligence, and global registration infrastructure - Represent Regulatory Affairs in product development, portfolio, commercialization, and other enterprise decision making forums We'll put each as
• . Requirements: Physical Requirements Ability to lift up to 20 pounds; Location: San Diego/On-site; Travel Willingness to travel up to approximately 10% of the time; Job Type Full-time. We could also include "Onsite role based in San Diego" already mentioned in About the role, but we still include location. Might be duplicate but okay. We'll make a
  with those items. Qualifications: Education And Experience section: "Minimum bachelor's degree in life sciences, engineering, regulatory affairs, or related discipline; advanced degree or RAC preferred Typically, 12+ years of progressively responsible medical device or IVD Regulatory Affairs experience, including substantial responsibility for regulated IVD product development, market authorization, and lifecycle management Demonstrated experience establishing regulatory strategy for complex diagnostic instruments, IVDs, molecular diagnostics, or similarly complex regulated products Experience leading regulatory programs across multiple major jurisdictions, including experience with FDA and/or EU IVDR; experience with both strongly preferred Demonstrated ability to advise senior executives and influence product, technical, clinical, quality, and commercial decisions without relying on positional authority Experience building or scaling a Regulatory Affairs function, team, operating model, or infrastructure Deep working knowledge of ISO 13485, ISO 14971, post-market requirements, labeling, change control, and applicable medical device/IVD regulatory frameworks Exceptional regulatory judgment, including the ability to assess and prioritize material regulatory and compliance risks and develop pragmatic, defensible solutions Proven track record of working well cross functionally and in a collaborative way Self-directed, proactive, and embodies an enterprise mindset" Wait some of those are actually skills. The list includes deep working knowledge etc. Those could be Skills. But we already have Skills section separate. To avoid duplication, we need to decide where each piece goes. The instruction: preserve ALL substantive information; do not invent or summarize away detail. So we need to include all info, but we can categorize them into sections as we see fit, as long as we don't lose info. We could put education/experience in Qualifications, and the knowledge/judgment etc in Skills. However the list includes both education/experience and skills. We'll split. Thus Qualifications: education, years of experience, experience establishing regulatory strategy, experience leading programs across jurisdictions, ability to advise senior executives, experience building/scaling RA function. That's the core qualifications. Skills: deep working knowledge of ISO..., exceptional regulatory judgment, proven track record of working well cross functionally, self-directed, proactive, embodies an enterprise mindset. Also maybe "ability to advise senior executives" already in qualifications; but we can keep. We must not duplicate. Let's extract precisely. From Education And Experience block: - Minimum bachelor's degree in life sciences, engineering, regulatory affairs, or related discipline; advanced degree or RAC preferred - Typically, 12+ years of progressively responsible medical device or IVD Regulatory Affairs experience, including substantial responsibility for regulated IVD product development, market authorization, and lifecycle management - Demonstrated experience establishing regulatory strategy for complex diagnostic instruments, IVDs, molecular diagnostics, or similarly complex regulated products - Experience leading regulatory programs across multiple major jurisdictions, including experience with FDA and/or EU IVDR; experience with both strongly preferred - Demonstrated ability to advise senior executives and influence product, technical, clinical, quality, and commercial decisions without relying on positional authority - Experience building or scaling a Regulatory Affairs function, team, operating model, or infrastructure Then after that, there is a line: "Deep working knowledge of ISO 13485, ISO 14971, post-market requirements, labeling, change control, and applicable medical device/IVD regulatory frameworks" Then: "Exceptional regulatory judgment, including the ability to assess and prioritize material regulatory and compliance risks and develop pragmatic, defensible solutions" Then: "Proven track record of working well cross functionally and in a collaborative way" Then: "Self-directed, proactive, and embodies an enterprise mindset" Thus we can put the first six bullets under Qualifications, and the last four under Skills. Now Benefits: "In addition to base compensation