Regulatory Affairs Specialist II

We need to produce HTML fragment with sections: About the role? Actually we need to use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Remove boilerplate. Preserve all substantive info. We need to parse the posting. Content: - Intro about Abbott (company description) maybe part of About the role? Could be "About the role" or "About Abbott"? The instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have "About the role" heading with description of role and company. - Responsibilities: list of duties: Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class III medical devices which may include software; Strategic Planning: Assist in development of regional regulatory strategy and update strategy based upon regulatory changes; Premarket: Assess acceptability of quality, preclinical and clinical documentation for submission filing; Compile, prepare, review and submit regulatory submission to authorities to support both investigational and commercial approval; Utilize technical regulatory skills to propose strategies on complex issues; Monitor impact of changing regulations on submission strategies; Monitor applications under regulatory review; Monitor and submit applicable reports to regulatory authorities; Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies; Negotiate and interact with regulatory authorities during development and review process to ensure submission approval; Postmarket: Maintain annual licenses, registrations, listings and patent information; Assist compliance with product postmarketing approval requirements; Submit and review change controls to determine level of change and consequent submission requirements; Analyze input of cumulative product changes to current product submissions. - Requirements/Qualifications: There's "Required Qualifications" and "Preferred Qualifications". We can combine into Requirements and Qualifications sections? The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have "Requirements" for required qualifications, "Qualifications" for preferred? Or maybe "Qualifications" for both required and preferred? But we have both sections. Could do "Required Qualifications" under Requirements heading, and "Preferred Qualifications" under Qualifications heading. Or combine? The instruction says prefer a few substantive sections over many thin ones. But we have both required and preferred; we could put both under "Qualifications" with subheadings? But we cannot add extra headings beyond those listed? It says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but suggests using those. Probably we should stick to those. So we can have "Requirements" for required qualifications, and "Qualifications" for preferred qualifications. Or we could merge both into one "Qualifications" section, but then we lose distinction. However the instruction says "Prefer a few substantive sections over many thin ones." Having both Requirements and Qualifications might be okay if they have content. We'll include both. - Skills: maybe we can extract skills from responsibilities and qualifications: e.g., communication, negotiation, matrix environment, technical regulatory skills, analytical thinking, problem-solving, knowledge of software/electrical regulations, PMA or investigational device submission experience, certification (RAC). Could create a Skills section. - Benefits: The posting includes benefits: "Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists". Also earlier: "You’ll also have access to : Career development with an international company where you can grow the career you dream of". So we have benefits. - Pay: The posting includes: "The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted." So we have pay. - Schedule: Not mentioned. So we should not include Schedule section. - Also location: on-site in New Brighton, MN. Could be part of About the role. We must not include boilerplate like EEO, equal opportunity, scam warning, application instructions, cookie/navigation/legal. Remove duplicated lines, like repeated "Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews." appears twice; we should keep only once or drop? Probably drop as it's boilerplate. Also "Apply Now Learn more about our health and wellness benefits..." is application instruction; we should drop that line. Also "Follow your career aspirations to Abbott for diverse opportunities..." is also boilerplate; drop. We must preserve all substantive information. So we need to keep the description of Abbott, mission, opportunity, responsibilities, qualifications, preferred qualifications, benefits, pay. We need to format as HTML fragment: use

for each section heading, then content:

for prose,

• for lists. We need to decide what goes into each section. About the role: Could include company description, mission, location, opportunity summary. Let's craft a paragraph. Responsibilities: list bullet points. Requirements: list bullet points of required qualifications. Qualifications: list bullet points of preferred qualifications. Skills: maybe list bullet points of skills extracted. Benefits: list bullet points. Pay: paragraph with pay range. We must not invent or summarize away detail. Must preserve all substantive information. So we need to include each piece of info exactly as given, not paraphrasing too much? We can rephrase slightly but must keep meaning. Probably okay to rewrite but not omit details. Let's extract substantive info: Company description: - Abbott is a global healthcare leader that helps people live more fully at all stages of life. - Portfolio of life-changing technologies spans spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. - 122,000 colleagues serve people in more than 160 countries. - Working at Abbott: you can do work that matters, grow, learn, care for yourself and family, be your true self and live a full life. - You’ll also have access to: Career development with an international company where you can grow the career you dream of. Mission (Structural Heart Business Mission): - Business purpose is to restore health and improve quality of life through design and provision of device and management solutions for treatment of structural heart disease. Opportunity: - Recruiting for a Regulatory Affairs Specialist to join team on-site in New Brighton, MN. - Oversee innovating Transcatheter Aortic Valve Implantation Franchise within Abbott Structural Heart Franchise. - As individual contributor, support product development activities to ensure both investigation and commercial regulatory approvals are achieved. - Provide regulatory input on design and development activities to cross functional teams including software development. - Provide submission authoring and compilation to meet program objectives and timelines. Responsibilities (the "What You’ll Work On" list): - Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class III medical devices which may include software. - Strategic Planning: Assist in development of regional regulatory strategy and update strategy based upon regulatory changes. - Premarket: Assess acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities to support both investigational and commercial approval. - Utilize technical regulatory skills to propose strategies on complex issues. - Monitor impact of changing regulations on submission strategies. - Monitor applications under regulatory review. - Monitor and submit applicable reports to regulatory authorities. - Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. - Negotiate and interact with regulatory authorities during development and review process to ensure submission approval. - Postmarket: Maintain annual licenses, registrations, listings and patent information. - Assist compliance with product postmarketing approval requirements. - Submit and review change controls to determine level of change and consequent submission requirements. - Analyze input of cumulative product changes to current product submissions. Required Qualifications: - Bachelor’s Degree or an equivalent combination of education and experience. - 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals). - 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. - Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. - Communicate effectively verbally and in writing. - Ability to work in a highly matrixed and geographically diverse environment. - Has broad knowledge of various technical alternatives and their potential impact on the business. - Exercise good and ethical judgment within policy and regulations. - Use in-depth knowledge of business functions and cross group dependencies/ relationships. - Define regulatory strategy with supervision. - Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues. Preferred Qualifications: - Master’s Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience. - 3 - 5 years of regulatory experience. - Knowledge of software and electrical regulations. - Ability to think analytically and have good problem-solving skills. - PMA or investigational device regulatory submission experience. - Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Benefits: - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with high employer contribution. - Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Pay: - The base pay for this position is $61,300.00 – $122,700.00. - In specific locations, the pay range may vary from the range posted. We should not include schedule. Now produce HTML. We need to ensure we don't include any extra text outside HTML fragment. We'll output something like:

  About the role

  ...

  Then

  Responsibilities

  ... etc. Make sure to close tags. Let's craft. About the role paragraph: combine company description, mission, opportunity, location. We'll write:

  Abbott is a global healthcare leader that helps people live more fully at all stages of life, with a portfolio spanning diagnostics, medical devices, nutritionals and branded generic medicines, employing 122,000 colleagues in over 160 countries. At Abbott you can do work that matters, grow, learn, care for yourself and family, be your true self and live a full life, with access to career development in an international company. The Structural Heart Business exists to restore health and improve quality of life through device and management solutions for structural heart disease. This Regulatory Affairs Specialist role is based on‑site in New Brighton, MN, supporting the Transcatheter Aortic Valve Implantation franchise within Abbott Structural Heart, providing regulatory input on design and development, authoring submissions, and ensuring investigational and commercial approvals.

  That seems to capture. Responsibilities: list each bullet as