Manager - Quality & 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. Remove boilerplate, navigation, legal, EEO, etc. Also remove duplicated lines, application instructions. Must preserve all substantive info. Let's parse the posting: First paragraph: "Versah, LLC is a pioneer in dental osteotomy and bone densification technologies and is now part of Nobel Biocare, a global implant and regenerative solutions leader within the Envista family of brands. Powered by its patented Densah® Bur technology and Osseodensification® approach, Versah helps clinicians worldwide enhance implant site preparation and regenerative procedures. This role supports global regulatory compliance while contributing to the maintenance and continuous improvement of the Quality Management System. It is well suited for a highly coachable regulatory professional with a solid RA foundation and working knowledge of quality systems who is eager to expand into broader quality system ownership over time. Success in this role means enabling global market access while maintaining audit-ready compliance, and it offers a strong opportunity to join a collaborative team and grow into increased ownership and leadership over time." That's about the role. So we can have

About the role

with that paragraph(s). Possibly split into multiple

but we can keep as one

. Next: "Duties And Responsibilities" then list bullet points. We'll create

Responsibilities

with

• each duty. List of duties: - Develop and lead global regulatory strategies to secure and maintain approvals for Versah’s medical device portfolio, with primary ownership of emerging markets. - Interpret global and regional regulations and translate them into clear product, project, and business requirements across the full product lifecycle. - Prepare, submit, and maintain international regulatory filings; serve as the primary contact for health authorities, including negotiation and timely resolution of regulatory questions. - Provide regulatory guidance to cross-functional partners (R&D, Engineering, Quality, Operations, Marketing, and Sales) to support both new product development and sustaining activities. - Ensure alignment with Envista and Nobel Biocare regulatory and quality frameworks, and drive maintenance and continuous improvement of the Versah Quality Management System in accordance with applicable regulations and standards. - Support and participate in external, third-party, and regulatory audits/inspections in collaboration with Regulatory and Quality leadership. - Support supplier qualification, incoming inspection/material review, and nonconformance management; support complaint investigations and CAPA; and maintain product traceability, quality records, and document control. - Oversee import/export regulatory compliance and ensure adherence to country-specific requirements for product distribution. - Manage and maintain global UDI compliance across all applicable markets. - Conduct regulatory assessments to inform business planning, market expansion, and product lifecycle decisions. - Monitor, interpret, and communicate changes in global medical device regulations to drive ongoing compliance and organizational awareness. That's all. Next: "Qualifications/skills Job requirements:" then bullet list. We need to decide sections: Qualifications, Skills, Requirements. The posting lumps them together. We could put them under Requirements or Qualifications. The instruction says use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Skills). We need to decide which sections have content. We have qualifications/skills list: - Bachelor’s degree in scientific or technical discipline - 5+ years of experience in medical device regulatory affairs, with exposure to quality systems - Strong working knowledge of medical device regulations and quality systems (e.g., 21 CFR 820, QMSR, ISO 13485, MDD & EU MDR). - Demonstrated experience leading regulatory strategies and interacting with global regulatory authorities. - RAPS certification or formal regulatory training are preferred. - Excellent critical thinking, problem‑solving, and decision‑making skills. - Strong written and verbal communication skills with the ability to influence at multiple organizational levels. - Proven ability to work independently, manage multiple priorities, and lead cross‑functional collaboration. We could split into Requirements (education, experience) and Skills (knowledge, abilities). But we can also put all under Qualifications. However we must not create empty sections. We'll decide to have Requirements (education + experience) and Skills (knowledge, abilities). Or we could have Qualifications (education+experience) and Skills (the rest). Let's see typical: Qualifications often include education and experience; Skills include abilities. We'll do:

  Requirements

  with Bachelor’s degree and 5+ years experience.

  Skills

  with the rest: strong working knowledge..., demonstrated experience..., RAPS certification..., excellent critical thinking..., strong written..., proven ability... Now Benefits, Pay, Schedule: The posting includes a paragraph about compensation: "IND123 Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans." That's about compensation and benefits. So we can have Benefits and Pay sections. However we need to check if we have specific content for Pay: The posting does not give a specific salary range or numbers; it just says compensation packages take into account factors, etc. The instruction says: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. The posting does state that total compensation package may include annual performance bonus, medical/dental/vision benefits, 401K match, etc. That's benefits info. It also mentions compensation decisions etc but not a specific pay range. Is that considered filler? It says "Actual compensation packages take into account a wide range of factors..." That's generic but still substantive? It's not a specific number but it's describing that compensation is variable. The instruction says avoid filler like "commensurate with experience" etc. This is somewhat similar but maybe still considered generic. However they also list specific benefits: annual performance bonus, medical/dental/vision benefits, 401K match, etc. That is substantive benefits info. So we can include Benefits section with those specifics. For Pay, we might not include because no specific pay range or number given. The instruction says never create Pay section unless posting actually states them. It does state compensation package may include bonus etc but that's more benefits. So we can omit Pay. Schedule: No mention of schedule (full-time, part-time, hours). So omit Schedule. Now we also need to include maybe a short paragraph for metadata like Job ID? The instruction says do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

  or drop it. There's "IND123" appears before compensation paragraph. That seems like a job ID or code. We should fold that into a short

  maybe at top or bottom? But we should not repeat job title. We could include a

  with the Job ID? However they said fold minor metadata into a short

  or drop it. So we could include a

  at the beginning:

  Job ID: IND123

  maybe. But is that considered minor metadata? Yes. We'll include a short

  with that. But we need to ensure we don't include boilerplate like EEO, legal, etc. We'll remove all that. Now produce HTML fragment:

  Job ID: IND123

  About the role

  Versah, LLC is a pioneer in dental osteotomy and bone densification technologies and is now part of Nobel Biocare, a global implant and regenerative solutions leader within the Envista family of brands. Powered by its patented Densah® Bur technology and Osseodensification® approach, Versah helps clinicians worldwide enhance implant site preparation and regenerative procedures. This role supports global regulatory compliance while contributing to the maintenance and continuous improvement of the Quality Management System. It is well suited for a highly coachable regulatory professional with a solid RA foundation and working knowledge of quality systems who is eager to expand into broader quality system ownership over time. Success in this role means enabling global market access while maintaining audit-ready compliance, and it offers a strong opportunity to join a collaborative team and grow into increased ownership and leadership over time.

  Responsibilities

  • Develop and lead global regulatory strategies to secure and maintain approvals for Versah’s medical device portfolio, with primary ownership of emerging markets.
  • Interpret global and regional regulations and translate them into clear product, project, and business requirements across the full product lifecycle.
  • Prepare, submit, and maintain international regulatory filings; serve as the primary contact for health authorities, including negotiation and timely resolution of regulatory questions.
  • Provide regulatory guidance to cross-functional partners (R&D, Engineering, Quality, Operations, Marketing, and Sales) to support both new product development and sustaining activities.
  • Ensure alignment with Envista and Nobel Biocare regulatory and quality frameworks, and drive maintenance and continuous improvement of the Versah Quality Management System in accordance with applicable regulations and standards.
  • Support and participate in external, third-party, and regulatory audits/inspections in collaboration with Regulatory and Quality leadership.
  • Support supplier qualification, incoming inspection/material review, and nonconformance management; support complaint investigations and CAPA; and maintain product traceability, quality records, and document control.
  • Oversee import/export regulatory compliance and ensure adherence to country-specific requirements for product distribution.
  • Manage and maintain global UDI compliance across all applicable markets.
  • Conduct regulatory assessments to inform business planning, market expansion, and product lifecycle decisions.
  • Monitor, interpret, and communicate changes in global medical device regulations to drive ongoing compliance and organizational awareness.

  Requirements

  • Bachelor’s degree in scientific or technical discipline
  • 5+ years of experience in medical device regulatory affairs, with exposure to quality systems

  Skills

  • Strong working knowledge of medical device regulations and quality systems (e.g., 21 CFR 820, QMSR, ISO 13485, MDD & EU MDR)
  • Demonstrated experience leading regulatory strategies and interacting with global regulatory authorities
  • RAPS certification or formal regulatory training are preferred
  • Excellent critical thinking, problem‑solving, and decision‑making skills
  • Strong written and verbal communication skills with the ability to influence at multiple organizational levels
  • Proven ability to work independently, manage multiple priorities, and lead cross‑functional collaboration

  Benefits

  • Annual performance bonus
  • Medical/dental/vision benefits
  • 401K match
  • Other applicable compensation plans
  We should not include Pay or Schedule sections. Check for any leftover boilerplate: We removed EEO, legal, etc. Also removed "Operating company:Nobel Biocare" maybe we could include as minor metadata? Could fold into a short p. But not required. The instruction says do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

  or drop it. "Operating company:Nobel