Regulatory Affairs Specialist

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Let's parse the posting. First paragraph: description of company, mission, products. That's about the role? Actually "Your impact:" then bullet list of duties. So we can have "About the role" maybe summarizing mission? But we must not repeat job title. We can include a short paragraph about the role's purpose. Then list of duties: "This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the US, Health Canada and CE documentation, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. Prepares robust regulatory applications/submissions and technical file documentation (either for FDA, Notified Bodies and Health Canada) to achieve departmental and organizational objectives. Conducts reviews of product and manufacturing changes for compliance with applicable regulations. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Work with cross-functional team to support product release process. Reviews protocols and reports to support regulatory submissions. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA), Health Canada and EU MDR regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities as assigned" That's responsibilities. Then "Our commitment to collaboration" paragraph about impact and collaboration, maybe part of About the role? Could be separate but we can include in About the role. Then "You’ll thrive in the role if you have:" list of qualifications: BA/BS degree, 2-4 years regulatory experience, experience with Class III, 510(k), PMA, EU submission, familiarity with regulatory requirements, strong communication, problem solving, ability to work independently, experience in enterprise/cross-division, matrixed environment, team/individual, fast-paced, leverage others, multitask, prioritize, meet deadlines, strong organizational, follow-up, attention to detail. That's qualifications/requirements/skills. We need to split into sections: Requirements, Qualifications, Skills. The posting lumps them; we can decide to put them under Requirements (or Qualifications). But we need to follow instruction: Use sections only when posting has real specific content for it. We can combine similar items into one section maybe "Requirements and Qualifications". But they want separate headings if content exists. We could put education and experience under "Requirements", skills under "Skills". However the list includes both hard requirements and soft skills. Could split: Requirements: BA/BS degree, 2-4 years regulatory experience with medical devices; experience with Class III medical devices highly preferred; experience with 510(k) applications, PMA supplements and US device regulations and experience with EU submission and other international medical device regulations and submissions; Must be familiar with regulatory requirement for medical devices in the US and EU (at a minimum) including Quality Systems and ISO standards. Skills: Strong verbal and written communication skills; Ability to identify and solve problems and work independently with little oversight; Experience working in a broader enterprise/cross-division business unit model preferred; Ability to work in a highly matrixed and geographically diverse business environment; Ability to work within a team and as an individual contributor in a fast-paced, changing environment; Ability to leverage and/or engage others to accomplish projects; Multitasks, prioritizes, and meets deadlines in timely manner; Strong organizational and follow-up skills, as well as attention to detail. That seems reasonable. Then "Our commitment to collaboration" paragraph could be part of About the role or maybe a separate "About the team" but not required. We'll include in About the role. Then pay and benefits: "Heartstream Transparency Details The pay range for this position is $70,000 to $90,000 annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus may be offered. Employees are eligible to participate in our comprehensive Heartstreams Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. At Heartstream, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case." Thus we have Pay and Benefits sections. Also schedule: "For this office-based teams, this means working in-person at our Bothell office at least 3 days per week." That's schedule info. Thus we will have sections: About the role, Responsibilities, Requirements, Skills, Benefits, Pay, Schedule. We must not include sections with filler like "commensurate with experience". We have actual content. We must not repeat job title as heading. Not include Job ID etc. We must output only HTML fragment, no /, no markdown fences. We'll produce something like:

About the role

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Responsibilities

• ...
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Requirements

• ...
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Skills

• ...
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Benefits

• ...
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Pay

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Schedule

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Make sure to preserve all substantive information. Let's extract exact sentences. About the role: combine first paragraph and "Our commitment to collaboration" paragraph. First paragraph: "Regulatory Affairs Specialist Heartstream is building on our 40+ year legacy of growth and innovation in emergency medical technology to continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. Heartstream includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions." Second: "Our commitment to collaboration Your work will directly improve the quality of emergency medical services and enhance patient safety and survival rates by making high-quality care accessible to more people around the world. As part of a number one provider of therapeutic care solutions, your contribution will help us continue to save more lives every year. With every project, you'll be making a world of difference.We believe collaboration is better together than apart. For this office-based teams, this means working in-person at our Bothell office at least 3 days per week." But schedule part we will move to Schedule section. So we should separate schedule sentence. Thus About the role paragraph: combine first paragraph and the collaboration impact sentences except schedule. Let's craft: "Regulatory Affairs Specialist Heartstream is building on our 40+ year legacy of growth and innovation in emergency medical technology to continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. Heartstream includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions. Our commitment to collaboration: Your work will directly improve the quality of emergency medical services and enhance patient safety and survival rates by making high-quality care accessible to more people around the world. As part of a number one provider of therapeutic care solutions, your contribution will help us continue to save more lives every year. With every project, you'll be making a world of difference. We believe collaboration is better together than apart." Now Responsibilities: list each duty as

. We'll keep them as separate bullet points. Responsibilities bullet list: - Performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the US, Health Canada and CE documentation, ensuring products and procedures comply with regulatory agency specifications. - Supports necessary regulatory activities required for product market entry. - Prepares robust regulatory applications/submissions and technical file documentation (either for FDA, Notified Bodies and Health Canada) to achieve departmental and organizational objectives. - Conducts reviews of product and manufacturing changes for compliance with applicable regulations. - Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. - Works with cross-functional team to support product release process. - Reviews protocols and reports to support regulatory submissions. - Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements. - Complies with U.S. Food and Drug Administration (FDA), Health Canada and EU MDR regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. - Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. - Performs other related duties and responsibilities as assigned. Make sure grammar: "Work with cross-functional team" -> "Works with cross-functional team". Now Requirements: bullet list: - BA or BS degree in a technical discipline. - Minimum 2-4 years of regulatory experience with medical devices; experience with Class III medical devices highly preferred. - Experience with either 510(k) applications, PMA supplements and US device regulations and experience with EU submission and other international medical device regulations and submissions. - Must be familiar with regulatory requirement for medical devices in the US and EU (at a minimum) including Quality Systems and ISO standards. Now Skills: bullet list: - Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization. - Ability to identify and solve problems and work independently with little oversight. - Experience working in a broader enterprise/cross-division business unit model preferred. - Ability to work in a highly matrixed and geographically diverse business environment. - Ability to work within a team and as an individual contributor in a fast-paced, changing environment. - Ability to leverage and/or engage others to accomplish projects. - Multitasks, prioritizes, and meets deadlines in timely manner. - Strong organizational and follow-up skills, as well as attention to detail. Now Benefits: bullet list from "Employees are eligible to participate in our comprehensive Heartstreams Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more." We could also mention "annual incentive bonus may be offered" but that's compensation maybe under Pay. We'll keep benefits as listed. Thus Benefits bullet list: - Generous PTO - 401k (up to 7% match) - HSA (with company contribution) - Stock purchase plan - Education reimbursement - (and much more) maybe we can include "and much more" as a bullet? Could be part of same bullet. We'll make one bullet: "Comprehensive Total Rewards benefits program including generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement, and much more." Now Pay: paragraph: "The pay range for this position is $70,000 to $90,000 annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus may be offered. At Heartstream, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each