Regulatory Affairs

We need to output HTML fragment with sections: About the role? The posting includes a job description paragraph at start: "The Regulatory Affairs candidate is responsible for ensuring global product compliance..." That's about the role. Then responsibilities list (multiple paragraphs). Then qualifications (Core Competencies and Qualifications). Also Additional Details includes schedule, pay range, remote option, travel, etc. We need sections: maybe About the role, Responsibilities, Requirements (or Qualifications), Benefits?, Pay, Schedule. We must only include sections when posting has real specific content. We have pay range: $104,774.00 - $163,710.00/yr plus eligibility for bonus, stock and benefits. So we can include Pay section. Schedule: "This job has a full time weekly schedule. It includes the option to work remotely." Also "Primarily local travel during the business day, with some out-of-area and overnight travel expected. Less than 20% travel is required." That's schedule/travel info. Could be Schedule section. Benefits: mention eligibility for bonus, stock and benefits. Could include Benefits section. However we need to avoid filler like "commensurate with experience". We have actual pay range, so Pay section is valid. Benefits: mention eligibility for bonus, stock and benefits. That's specific enough? It says "plus eligibility for bonus, stock and benefits." That's somewhat generic but still mentions benefits. Could include Benefits section with that line. Schedule: we have full-time weekly schedule, option to work remotely, travel less than 20%. That's specific enough. We must not repeat job title as heading. No Job ID. Remove boilerplate like EEO etc. Also remove application instructions, etc. We need to use

for section headings. Use

• for any list of duties/requirements/benefits. Use

  for prose. We need to preserve all substantive information. So we need to include all responsibilities, qualifications, core competencies, etc. We'll need to break them into lists where appropriate. Let's extract sections: About the role: first paragraph(s) describing role: "The Regulatory Affairs candidate is responsible for ensuring global product compliance and adherence to applicable regulatory requirements. This role supports regulatory submissions for product marketing in international markets and contributes to maintaining compliance across the company’s IVD portfolio. The position supports new product development by providing regulatory input and guidance throughout the product lifecycle from design and development through commercialization to ensure compliance and timely market access. Responsibilities also include monitoring evolving global regulations, assessing their impact on company operations, and supporting updates to processes and documentation as needed. Additional activities include maintaining regulatory documentation, assisting with post-market compliance, and contributing to internal training and continuous improvement initiatives within the Regulatory Affairs function." That's a prose paragraph; could be

  . Then list of specific responsibilities: after that, there is a series of sentences starting with "Prepare, coordinate, and submit regulatory documentation..." etc. Those are a list of duties. We'll put them in

  • . Then Core Competencies: list of bullet-like sentences. Could be
    • . Qualifications: list of bullet-like sentences. Additional Details: schedule, pay, benefits, travel, remote option, etc. We need to ensure we don't create sections with placeholder text. We'll include About the role, Responsibilities, Core Competencies, Qualifications, Pay, Benefits, Schedule. Check if any section content is just filler: Pay: we have actual numbers and bonus/stock/benefits. Good. Benefits: we have eligibility for bonus, stock and benefits. Might be considered vague but it's specific mention. Could combine Benefits with Pay? But instruction: prefer few substantive sections over many thin ones. Could merge Pay and Benefits into one "Compensation and Benefits" section? But headings are prescribed: we can use Benefits and Pay separately if they have content. However we could also combine into one section named "Compensation and Benefits" but the instruction says use

      for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It suggests we can use those headings; we could also use other headings? It says use

      for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should stick to those headings. So we can have Pay and Benefits separate. Schedule: we have full-time weekly schedule, option to work remotely, travel less than 20%. That's specific. Now we need to remove boilerplate: EEO, equal opportunity, scam-warning, application instructions, etc. Also remove duplicated lines. We need to output only HTML fragment. Let's craft. First, About the role:

      About the role

      ...

      Responsibilities:

      Responsibilities

      • ... each duty.
      We need to split duties into items. Let's list them: - Prepare, coordinate, and submit regulatory documentation and product registrations for key global markets, including the U.S. (FDA), EU (IVDR), Canada, LATAM, Asia-Pacific, Middle East, and MDSAP-participating countries, ensuring timely approvals and continued market access. - Compile, review, and maintain regulatory technical documentation, including technical files, GSPRs, and CERs, to ensure compliance with IVDR and country-specific requirements. - Partner with R&D, Quality, and Commercial teams to integrate regulatory requirements into product development, design control, labeling, and change control processes. - Ensure company-wide compliance with cGMP and established procedures by collaborating with Quality Systems on adherence to GMP/QSR, ISO 13485, and MDSAP standards. - Perform product risk assessments and support evaluation of complaints and non-conformances; assist with investigation and documentation. - Manage and support recalls, Medical Device Reporting (MDR), advisory notices, and related post-market regulatory reporting. - Provide strategic regulatory guidance on submission planning, global compliance strategies, risk classification, and literature research. - Research and interpret global regulations to assess impact and recommend actionable compliance strategies. - Manage product registration, listing, and licensing activities, including renewal of business licenses in global markets. - Develop and maintain regulatory SOPs, guidelines, templates, and training content; deliver Regulatory Affairs and company-wide regulatory compliance training. - Review and approve product labeling, IFUs, user manuals, SDSs, and promotional content for regulatory compliance. - Monitor complaint-handling systems and support CAPA management to ensure effective resolution and prevention of recurrence. - Track changes in global regulatory requirements and perform gap analyses to ensure continued compliance and proactive remediation. - Generate and manage import/export documentation and facilitate customs clearance for product distribution. - Lead or support global Post-Market Surveillance (PMS) activities, including complaint trend analysis, vigilance reporting, and preparation of PMS documentation in accordance with IVDR. - Develop and execute Post-Market Performance Follow-up (PMPF) plans to gather performance data, literature, and user feedback for integration into CERs and risk management. - Contribute to departmental continuous improvement initiatives to enhance process efficiency, regulatory compliance, and documentation quality. - Support internal and external audits and inspections by regulatory authorities and notified bodies; prepare documentation and coordinate responses to audit findings. - Assess the regulatory impact of product and process changes and contribute to the change control process to ensure timely and compliant implementation. - Coordinate with external regulatory consultants or local agents for international submissions; support budgeting and planning activities for regulatory projects. - Support R&D throughout the product development process, from concept and feasibility through design, verification/validation, and commercialization, to ensure regulatory requirements are met at every stage. - Provide ongoing regulatory support for marketed products, including evaluation of design or process changes, post-market modifications, and lifecycle management activities to maintain global compliance. That's many items. Now Core Competencies: list: - Practical experience in the IVD field, with a solid understanding of regulatory requirements. - Knowledge of compliance requirements related to IVD Regulation (EU) 2017/746, NMPA, MFDS, AMDD, and other relevant markets. - Familiarity with international standards and regulations applicable to IVD devices, including ISO 13485:2016, ISO 14971:2019, and MDSAP. - Strong analytical and problem-solving skills, with the ability to investigate and resolve regulatory issues. - Effective interpersonal skills and the ability to collaborate within cross-functional teams. - Strong organizational skills, attention to detail, and ability to manage multiple priorities and meet deadlines with some guidance. - Clear oral and written communication skills appropriate for internal and external stakeholders. - Experience with eQMS platforms such as MasterControl, AssurX, or Veeva Vault QMS. Now Qualifications: - Bachelor’s degree or equivalent experience. - Minimum of three years of experience in the regulated medical device, IVD, or a related industry. - Strong knowledge of international submissions across LATAM, the EU, Asia, and MDSAP countries. - Experience with antibody-based diagnostics is strongly preferred. - Excellent leadership, communication, and project management skills. - Familiarity with eQMS platforms, including MasterControl, Veeva Vault, or AssurX, is highly desirable. - Primarily local travel during the business day, with some out-of-area and overnight travel expected. - Less than 20% travel is required. Note: travel items maybe belong to Schedule section, but they are in Qualifications? Actually they appear under Qualifications block? In the posting they appear after Qualifications? Actually they appear after Qualifications: "Primarily local travel during the business day, with some out-of-area and overnight travel expected. Less than 20% travel is required." That's under Additional Details? It appears after Qualifications but before Additional Details? Let's see original: after Qualifications block there is "Primarily local travel during the business day, with some out-of-area and overnight travel expected. Less than 20% travel is required." Then "Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least September 25, 2026 or until the job is no longer posted. The full-time equivalent pay range for this position is $104,774.00 - $163,710.00/yr plus eligibility for bonus, stock and benefits. ..." So travel is separate but could go under Schedule. We'll put travel under Schedule. Now Additional Details: schedule, pay, benefits, remote option, application deadline (we should drop application instructions). Also we need to drop "Applications for this job will be accepted until at least September 25, 2026 or until the job is no longer posted." That's application instruction; drop. Also drop "Our pay ranges are determined by role, level, and location..." etc? That's part of pay details but we can keep some? It's somewhat generic but still part of pay info. However we should keep substantive pay range. The rest about determination may be considered boilerplate? It's still about pay but maybe we can keep short sentence: "Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training." That's somewhat generic but still specific to how pay determined. Might be okay. However we might keep just the pay range and eligibility for bonus, stock, benefits. The instruction says: do not 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 states pay range and eligibility for bonus, stock and benefits. So we can include Pay section with that sentence. The extra explanation about how pay determined may be considered filler? It's not placeholder but still somewhat generic. Safer to include only the concrete pay range and eligibility for bonus, stock and benefits. We'll keep: "The full-time equivalent pay range