Senior Associate, Regulatory Affairs (Hybrid)

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    "ShortDescriptionStr": "Provides regulatory support and expertise associated with global and US registration of medical device products, including in-depth analysis of the requirements and tracking of deliverables. With oversight, supports creation of global regulatory strategies and assists in execution including creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management.",
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    "ExternalDescriptionStr": "<div>\n <p><strong>Position Summary&nbsp;</strong></p>\n <p style=\"margin-left:5pt\">Provides regulatory support and expertise associated with global and US registration of medical device&nbsp;products, including in-depth analysis of the requirements and tracking of deliverables. With&nbsp;oversight, supports creation of global regulatory strategies and assists in execution including&nbsp;creation and maintenance of global registration dossiers. Assures full regulatory compliance of all&nbsp;documentation&nbsp;for submissions and change management.</p>\n <p><strong>Essential Duties &amp; Responsibilities</strong></p>\n <ul>\n  <li>Provides regulatory advice and support to assigned products/teams.&nbsp;Identifies and&nbsp;communicates registration needs and strategies.&nbsp;Maintains awareness of applicable&nbsp;regulations.</li>\n  <li>Plans and organizes registration packages for device products.&nbsp;Prepares registration packages&nbsp;in&nbsp;line with local regulatory requirements&nbsp;and guidelines.</li>\n  <li>With&nbsp;oversight,&nbsp;serves&nbsp;as&nbsp;a&nbsp;liaison&nbsp;with&nbsp;regulatory&nbsp;agencies&nbsp;pertaining&nbsp;to&nbsp;assigned&nbsp;products.&nbsp;Assists&nbsp;in&nbsp;the&nbsp;preparation&nbsp;of&nbsp;agency&nbsp;meeting&nbsp;packages&nbsp;and&nbsp;strategies&nbsp;for&nbsp;agency&nbsp;meetings.</li>\n  <li>Evaluates manufacturing and labeling changes for regulatory impact.&nbsp;Accurately describes&nbsp;these&nbsp;changes for ease of regulatory&nbsp;agency review.</li>\n  <li>Work with region and country RA counterparts to evaluate changes for regulatory impact and&nbsp;to ensure compliance with applicable regulations.&nbsp;Accurately describes these changes for ease&nbsp;of&nbsp;regulatory agency review.</li>\n  <li>Represents Global Regulatory Affairs at research and development meetings and presents&nbsp;agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned&nbsp;product&nbsp;or project team.</li>\n </ul>\n <p><strong>Knowledge &amp; Skills</strong></p>\n <ul>\n  <li>Review and approve critical documents, seeking guidance when necessary.&nbsp;Review technical&nbsp;reports&nbsp;and&nbsp;determine&nbsp;acceptability&nbsp;for&nbsp;regulatory submission.</li>\n  <li>Identify registration documentation deficiencies and work with colleagues to accomplish&nbsp;resolution.</li>\n  <li>Interpret global regulations and assure regulatory compliance, minimizing development costs&nbsp;and cycles.</li>\n  <li>Define&nbsp;and&nbsp;negotiate&nbsp;regulatory&nbsp;strategy&nbsp;with&nbsp;supervision.</li>\n  <li>Exercise&nbsp;good&nbsp;judgment&nbsp;within&nbsp;policy&nbsp;and&nbsp;regulations.</li>\n  <li>Responsible for tracking and completion of assigned registration activities.&nbsp;</li>\n  <li>Accountable for&nbsp;accuracy of work and meeting multiple, simultaneous deadlines.&nbsp;Missed registration&nbsp;deadlines or inaccurate registration packages can delay regulatory approvals, which can result&nbsp;in&nbsp;missed sales or&nbsp;regulatory action&nbsp;letter.</li>\n  <li>Follows scientific arguments, identifies regulatory scientific data needs and solves regulatory&nbsp;issues&nbsp;with alignment of&nbsp;regulatory&nbsp;management.</li>\n  <li>Presents&nbsp;scientific&nbsp;data&nbsp;effectively&nbsp;orally&nbsp;and&nbsp;in&nbsp;writing&nbsp;in&nbsp;a&nbsp;logical and&nbsp;persuasive&nbsp;manner.</li>\n  <li>Provides&nbsp;daily&nbsp;regulatory&nbsp;support&nbsp;to&nbsp;new&nbsp;product&nbsp;development&nbsp;teams&nbsp;and&nbsp;commercial&nbsp;support&nbsp;with&nbsp;guidance.</li>\n  <li>Participates in preparing regulatory strategies.&nbsp;Reviews submissions, regulatory&nbsp;commitments, strategy decisions, and changes to resource allocations with manager prior to&nbsp;execution.</li>\n  <li>Acts&nbsp;independently&nbsp;on&nbsp;all&nbsp;routine&nbsp;issues,&nbsp;makes&nbsp;judgment&nbsp;and&nbsp;executes.</li>\n </ul>\n <p><strong>Minimum Qualifications, Education &amp; Experience&nbsp;</strong></p>\n <ul>\n  <li>Must be at least 18 years of age</li>\n  <li>High School Diploma required</li>\n  <li>Bachelor’s degree from an accredited college&nbsp;in pharmacy, biology, chemistry, pharmacology, engineering or&nbsp;related&nbsp;subject&nbsp;or university is required</li>\n  <li>Master’s&nbsp;Degree&nbsp;or&nbsp;P.H.D&nbsp;preferred</li>\n  <li>RAC&nbsp;Certification&nbsp;preferred</li>\n  <li>Seven plus years of experience in Medical Products Industry in Regulatory Affairs.</li>\n  <li>Able&nbsp;to&nbsp;lead&nbsp;scientific&nbsp;arguments&nbsp;and&nbsp;apply&nbsp;analytical&nbsp;and&nbsp;logical&nbsp;reasonings.</li>\n  <li>Ability&nbsp;to&nbsp;effectively&nbsp;prioritize&nbsp;workload&nbsp;and&nbsp;multitask&nbsp;with&nbsp;minimal&nbsp;supervision.</li>\n  <li>Good&nbsp;interpersonal&nbsp;skills.</li>\n  <li>Good&nbsp;oral&nbsp;and&nbsp;written&nbsp;communications&nbsp;skills.</li>\n  <li>Demonstrated&nbsp;project&nbsp;management&nbsp;skills.</li>\n  <li>Demonstrated&nbsp;critical&nbsp;thinking,&nbsp;contingency&nbsp;planning&nbsp;and&nbsp;negotiating&nbsp;skills.</li>\n  <li>Understanding of regulatory and business needs with ability to establish direction and&nbsp;influence&nbsp;cross functional team members.</li>\n </ul>\n <p><strong>Work Environment</strong></p>\n <ul>\n  <li>This is largely a sedentary role.&nbsp;</li>\n  <li>This job operates in a professional office environment and routinely uses standard office equipment.</li>\n  <li>Typically requires travel 5-20% of the time</li>\n </ul>\n <p>&nbsp;</p>\n <p>Salary Range - $97,500 - $139,750</p>\n <p>The salary range displayed represents the annual base salary we reasonably expect to pay for this role.&nbsp; The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.</p>\n <p>&nbsp;ICU Medical provides a comprehensive total rewards package that includes:</p>\n <ul>\n  <li>Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan</li>\n  <li>A wide range of benefit options at affordable rates</li>\n  <li>Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement</li>\n </ul>\n <p>&nbsp;Additional information on health and welfare benefit offerings can be found at <a href=\"https://www.icumed.com/about-us/careers/investing-in-your-future/\" target=\"_blank\" rel=\"nofollow\">https://www.icumed.com/about-us/careers/investing-in-your-future/</a>.</p>\n</div>",
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    "CorporateDescriptionStr": "<p class=\"MsoNormal\">ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.</p>\n<p class=\"MsoNormal\">With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.</p>\n<p class=\"MsoNormal\">We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:</p>\n<ul style=\"margin-top:0in\">\n <li>Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.</li>\n <li>The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.</li>\n <li>IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.</li>\n <li>Significant US IV solutions manufacturing and supply capabilities.</li>\n</ul>\n<p class=\"MsoNormal\"><b>ICU Medical EEO Statement:</b></p>\n<p class=\"MsoNormal\">ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.&nbsp;</p>\n<p class=\"MsoNormal\">If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [email protected]. We are committed to providing equal access and opportunities for all candidates.</p>\n<div>\n <p class=\"MsoNormal\"><span><a href=\"https://www.icumed.com/media/lwkcbbam/icu-medical-eeo-policy-statement-2025.pdf\" target=\"_blank\" rel=\"nofollow\">ICU Medical EEO Policy Statement</a></span></p>\n <p class=\"MsoNormal\"><a href=\"https://www.icumed.com/media/0mrnh211/know_your_right_2023-2.pdf\" target=\"_blank\" rel=\"nofollow\"><span>Know Your Rights: Workplace Discrimination is Illegal Poster</span></a><span></span></p>\n <p class=\"MsoNormal\"><a href=\"https://www.icumed.com/media/1qwexl5a/icu-medical-job-applicant-privacy-notice-october-2024.pdf\" target=\"_blank\" rel=\"nofollow\"><span>ICU Medical CCPA Notice to Job Applicants</span></a></p>\n</div>",
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