Sr. Manager, Regulatory Affairs

We need to output HTML fragment with sections: About the role? The description includes "Description" then role expectations etc. We need headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We have content: Department, Location, Description (role description). Then "Role expectations" with bullet-like paragraphs. Then "Education" with requirements. Then "Skills" with bullet list. Then "Travel Requirement". Then "Pay Transparency" (pay info). Then "General Description Of All Benefits" (benefits). Then other boilerplate to remove. We need to map to headings: - About the role: could be the initial description paragraph(s). Use

About the role

then

with description. - Responsibilities: from "Role expectations" paragraphs (multiple). Use

• each bullet? The text is paragraph sentences; we can split into list items each sentence? Better to keep as
  • each distinct responsibility. We'll parse sentences. - Requirements: Education section: Bachelor’s degree..., Experience..., etc. Could be
    • . - Qualifications: maybe overlapping with Requirements? Could combine? But we need separate sections only if content. We have Education (requirements) and Skills (skills). Qualifications maybe not distinct; we could skip Qualifications if no distinct content beyond requirements. But we have "Education" which is qualifications. Could treat as Qualifications. However we already have Requirements. The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to decide which sections to include based on content. We have: - About the role: description paragraph. - Responsibilities: role expectations paragraphs. - Requirements: education and experience (Bachelor’s degree, 10+ years, etc.) - Qualifications: maybe not separate; we could skip. - Skills: list of skills. - Benefits: benefits description. - Pay: pay transparency paragraph. - Schedule: travel requirement? Actually schedule is about work schedule; we have travel requirement up to 10% travel. That's not schedule but could be considered Schedule? The instruction says Schedule section only if posting actually states them. Travel requirement is not schedule but maybe we can treat as Schedule? Better to not create Schedule if not explicit schedule like full-time, part-time, shift. Travel requirement is not schedule. So we omit Schedule. Thus sections: About the role, Responsibilities, Requirements, Skills, Benefits, Pay. We need to preserve all substantive information, not invent or summarize away detail. Must not include boilerplate like EEO, privacy, etc. We need to extract details precisely. Let's parse the posting. First lines: Department: Quality Location: US-North Carolina-Raleigh Description The Sr. Regulatory Affairs Manager will be responsible for developing and executing regulatory strategies for medical devices in accordance with health authority regulations/guidance and global standards. The devices in scope include physical devices, software in medical device (SiMD) and software as a medical device (SaMD). In particular, this role will (a) provide strategic device regulatory decisions on strategies and risk management of the diagnostic device and AI/ML product portfolio throughout the entire product lifecycle, (b) solve unique and strategic challenges with broad impact on the growing diagnostic device portfolio in a dynamic regulatory environment, and (c) establish trusted relationships with industry partners and interface with health authorities with the goal to influence industry best practices and regulatory landscape intentionally. This position requires in depth and breadth of US device regulatory knowledge and experience throughout the product life cycle, strong leadership, critical thinking, collaboration and influencing skills. Ex-health authority regulatory experience is highly desirable. That's the description. Then "Role expectations" heading (not to be used as heading but we will use Responsibilities). Under Role expectations: Regulatory Strategy and Execution Develop and implement regulatory strategies for diagnostic devices including physical devices, software in medical device (SiMD) and software as a medical device (SaMD). Ensure regulatory submissions are well-organized, scientifically accurate, of high quality, and presented in a way that facilitates agency review and fulfills strategic goals. Partners with relevant internal business partners and lead the effort to solve technical and strategic challenges with broad impact on the diagnostic device portfolio, including product concept development, product architecture and technical development, study design, verification and validation strategies, etc. Articulate potential regulatory scenarios and the associated risks/mitigations and recommend a path forward in alignment with business objectives. Monitor external regulatory trends, including but not limited to the involving landscape of AI/ML initiatives to anticipate potential business/regulatory risks at the portfolio level. Communicate potential risks and lead the implementation of regulatory measures to ensure competitive advantages and success of the product portfolio. Act as RA SME in assigned area and contribute to RA department priorities with a focus on enhancing regulatory intelligence and driving regulatory strategy execution. Serve as the regulatory subject matter expert for deploying AI/ML-enabled functions across existing and planned products, and promote the use of emerging regulatory tools, such as Predetermined Change Control Plans, when appropriate to support business objectives and product lifecycle needs. As assigned by management, may support global submission activities (new product development, sustaining products, new/updated features, etc.), regulatory compliance or operation activities (recall, non-conformance, audit, process improvement, country approval, distribution control, annual update, post-market surveillance, regulatory intelligence, labeling, claims, advertising promotional materials, etc.) External Influencing, Capability and Culture Building Influence and interact directly with Health Authorities on policy issues that support our portfolio. Build trusted relationships with industry partners and Health Authorities. Represent Align Technology in relevant external influencing venues. Lead the effort to create external regulatory positions and disseminating the positions via external influencing venues (e.g. working/trade groups, publications, presentations, etc.). Actively engaged in coaching and mentoring internal cross-functional team on regulatory strategy and risk management. Build and cultivate a strong partnership with internal business partners. That's responsibilities. Then "Education" heading: What we're looking for Bachelor’s degree in engineering, regulatory affairs, quality, or related field. Experience: 10+ years of experience in regulatory affairs, quality, device development or related field in the medical device industry. Higher education (Masters, Ph.D. etc.) can substitute for years of experience. Extensive experience with diagnostic SaMD products, AI/ML-enabled SaMD products, headless products, and US FDA regulations/guidance and global standards. Ex-health authority regulatory experience is highly desirable. Demonstrated success in developing strong working relationships with regulators and external groups (e.g., trade associations) to influence effectively and bring about consensus on policies that support business objectives. That's requirements/qualifications. Then "Skills:" heading: Skills: Solid understanding of Design Control requirements, FDA QSR regulations, and ISO 13485 MDSAP quality System Management Keen ability to prioritize work and execute in an environment of competing priorities. Excellent time and project management skills with the ability to multi-task Strong analysis, organizational, follow-up skills, as well as attention to detail. Exercises good judgement to research, analyze, evaluate, plan and solutioning, and execution to deliver results or resolve issues. Being able to drive, coordinate with stakeholders and activities to analyze issues, situation and come up solution. Familiarity with digital platforms, data analytics, and AI-driven solutions for quality and regulatory processes is highly desirable. Communication: Demonstrated strategic/critical thinking ability and drive for successful regulatory outcomes. Result oriented with strong initiative and accountability. Able to communicate complex ideas/issues and influence others (including senior leaders) to adopt a different point of view. Ability to work well in a matrixed, dynamic environment with flexibility and agility. Teamwork: Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Then "Travel Requirement": Travel Requirement Up to 10% international and domestic travel necessary. Then "Pay Transparency" paragraph. Then "General Description Of All Benefits" heading with benefits details. We need to output HTML with sections. We must not repeat job title as heading. Not include Job ID etc. We must not include boilerplate like Applicant Privacy Policy, Equal Opportunity Statement, etc. We must preserve all substantive information: that includes Department and Location? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. Should we include Department and Location? They are substantive. Where to put? Could be in About the role paragraph or a separate meta paragraph. Since we cannot add extra headings not listed, we could include them in a

      under About the role or maybe a separate

      before sections. The instruction: Output ONLY the HTML fragment — no /, no markdown code fences. It didn't forbid extra paragraphs outside sections. So we can include a

      with Department and Location before sections. Thus:

      Department: Quality. Location: US-North Carolina-Raleigh.

      But we should avoid adding markup not requested? It's okay to use but not required. Could just plain text. Better:

      Department: Quality. Location: US-North Carolina-Raleigh.

      Then About the role section:

      About the role

      ... description paragraph(s)

      We need to preserve the description exactly as given (maybe two paragraphs). The description includes multiple sentences. We'll put as one

      . Then Responsibilities:

      Responsibilities

      with each responsibility as
      • . Need to split into logical items. We'll create list items for each bullet sentence. We have two categories: Regulatory Strategy and Execution (multiple items) and External Influencing, Capability and Culture Building (multiple items). We'll just list all. Let's extract each sentence: - Develop and implement regulatory strategies for diagnostic devices including physical devices, software in medical device (SiMD) and software as a medical device (SaMD). - Ensure regulatory submissions are well-organized, scientifically accurate, of high quality, and presented in a way that facilitates agency review and fulfills strategic goals. - Partners with relevant internal business partners and lead the effort to solve technical and strategic challenges with broad impact on the diagnostic device portfolio, including product concept development, product architecture and technical development, study design, verification and validation strategies, etc. - Articulate potential regulatory scenarios and the associated risks/mitigations and recommend a path forward in alignment with business objectives. - Monitor external regulatory trends, including but not limited to the involving landscape of AI/ML initiatives to anticipate potential business/regulatory risks at the portfolio level. Communicate potential risks and lead the implementation of regulatory measures to ensure competitive advantages and success of the product portfolio. - Act as RA SME in assigned area and contribute to RA department priorities with a focus on enhancing regulatory intelligence and driving regulatory strategy execution. - Serve as the regulatory subject matter expert for deploying AI/ML-enabled functions across existing and planned products, and promote the use of emerging regulatory tools, such as Predetermined Change Control Plans, when appropriate to support business objectives and product lifecycle needs. - As assigned by management, may support global submission activities (new product development, sustaining products, new/updated features, etc.), regulatory compliance or operation activities (recall, non-conformance, audit, process improvement, country approval, distribution control, annual update, post-market surveillance, regulatory intelligence, labeling, claims, advertising promotional materials, etc.) - Influence and interact directly with Health Authorities on policy issues that support our portfolio. - Build trusted relationships with industry partners and Health Authorities. - Represent Align Technology in relevant external influencing venues. - Lead the effort to create external regulatory positions and disseminating the positions via external influencing venues (e.g. working/trade groups, publications, presentations, etc.). - Actively engaged in coaching and mentoring internal cross-functional team on regulatory strategy and risk management. - Build and cultivate a strong partnership with internal business partners. That's 12 items. Now Requirements:

        Requirements

        with items: - Bachelor’s degree in engineering, regulatory affairs, quality