Xylem is a Fortune 500 global water solutions company dedicated to advancing sustainable impact and empowering the people who make water work every day. As a leading water technology company with 23,000 employees operating in over 150 countries, Xylem is at the forefront of addressing the world's most critical water challenges. We invite passionate individuals to join our team, dedicated to exceeding customer expectations through innovative and sustainable solutions.The Role:The Senior Product Compliance Analyst is focused on product compliance to regulatory requirements for medical devices in the US, Canada and in various other countries.  This role ensures our products meet all applicable regulatory standards for safety, efficacy, and quality. The position works across departments to prepare and submit applications for product approvals, licenses, and permits, and monitor post-market compliance. They also advise on regulatory requirements during product development, manufacturing, distribution and service.Core Responsibilities:•    The Senior Product Compliance Analyst will develop US, Canada and emerging market assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory agency interaction •    The Senior Product Compliance Analyst will assist in training of staff for regulatory requirements as part of the role •    Perform facility inspections for compliance to 21CFR820 and ISO1345 Evoqua policy and procedures assuring compliant operation •    Conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments for new and modified products •    Assume responsibility for project submissions for 510(k) premarket notifications, Technical File Documentation, and license submission/amendments •    Communicate with management to ensure timely notification of regulatory changes as appropriate •    Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts •    Interact and negotiate with regulatory authorities during the development (i.e Q-Sub, change notifications, etc.) and submission review •    Support regulatory agency and/or notified body audits by as needed •    Participate in development and approval of risk activities as well as other deliverables as related to medical device projects •    Review and approve all Labeling (product, advertising and promotional) and ensure claims are substantiated •    Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders •    Support customer inquiry related to compliance issues •    Comply with Xylem Code of Ethics, all Company policies, rules, and proceduresRequired Qualifications: •    Bachelor’s degree in a Science or Engineering field, or equivalent work experience •    5+ years of Medical Device Regulatory Affairs experience, domestic and international •    3 years of experience with Class II or III medical devices •    Proven history of successful domestic and/or international submissions Preferred Qualifications: •    Strong analytical and critical thinking skills •    Strong verbal and writing communication skills •    Ability to manage and prioritize multiple projects to meet deadlines that align with Xylem objectives •    Proven track record of working as a team player to overcome obstacles and complete tasks through collaboration •    Proficiency in MS Office software programsJoin the global Xylem team to be a part of innovative technology solutions transforming water usage, conservation, and re-use. Our products impact public utilities, industrial sectors, residential areas, and commercial buildings, with a commitment to providing smart metering, network technologies, and advanced analytics for water, electric, and gas utilities. Partner with us in creating a world where water challenges are met with ingenuity and dedication; where we recognize the power of inclusion and belonging in driving innovation and allowing us to compete more effectively around the world.<div>At Xylem, you'll not only contribute to solving water issues but also have the chance to make a difference through our paid Volunteer Program, Xylem Watermark. We prioritize our employees' well-being through inclusion and belonging as well as our Employee Resource Groups (ERG). Proud to be an Equal Employment Opportunity (including disability and veterans) and Affirmative Action workplace, Xylem fosters an inclusive environment free from discrimination or harassment. </div><div>  </div><div>Please note that the information in this job description outlines the general nature of the position and is not an exhaustive list of duties. Xylem is dedicated to providing reasonable accommodations to enable all employees to perform their essential job functions. We reserve the right to modify this job description and assign additional duties as needed. Embrace the opportunity to be part of Xylem's transformative journey in shaping the future of water technology! #XylemCareers #GlobalImpact #WaterInnovation </div>

Xylem is the global leader in advanced technologies, solutions and services that address the world&rsquo;s biggest water challenges. We enable our customers to dramatically improve the way water and wastewater is used, managed, conserved, re-used and returned to nature. At every level, our global team is committed to access, equity, inclusion, and diversity. Our goal is for all our colleagues to be involved, respected, valued, connected, and free to bring their authentic selves and ideas. If you are excited and passionate about solving water, we want to hear from you.

Senior Product Compliance Analyst

Xylem is a Fortune 500 global water solutions company dedicated to advancing sustainable impact and empowering the people who make water work every day. As a leading water technology company with 23,000 employees operating in over 150 countries, Xylem is at the forefront of addressing the world's most critical water challenges. We invite passionate individuals to join our team, dedicated to exceeding customer expectations through innovative and sustainable solutions.The Role:The Senior Product Compliance Analyst is focused on product compliance to regulatory requirements for medical devices in the US, Canada and in various other countries. &nbsp;This role ensures our products meet all applicable regulatory standards for safety, efficacy, and quality. The position works across departments to prepare and submit applications for product approvals, licenses, and permits, and monitor post-market compliance. They also advise on regulatory requirements during product development, manufacturing, distribution and service.Core Responsibilities:•&nbsp;&nbsp;&nbsp;&nbsp;The Senior Product Compliance Analyst&nbsp;will develop US, Canada and emerging market assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory agency interaction •&nbsp;&nbsp;&nbsp;&nbsp;The Senior Product Compliance Analyst&nbsp;will assist in training of staff for regulatory requirements as part of the role •&nbsp;&nbsp;&nbsp;&nbsp;Perform facility inspections for compliance to 21CFR820 and ISO1345 Evoqua policy and procedures assuring compliant operation •&nbsp;&nbsp;&nbsp;&nbsp;Conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments for new and modified products •&nbsp;&nbsp;&nbsp;&nbsp;Assume responsibility for project submissions for 510(k) premarket notifications, Technical File Documentation, and license submission/amendments •&nbsp;&nbsp;&nbsp;&nbsp;Communicate with management to ensure timely notification of regulatory changes as appropriate •&nbsp;&nbsp;&nbsp;&nbsp;Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts •&nbsp;&nbsp;&nbsp;&nbsp;Interact and negotiate with regulatory authorities during the development (i.e Q-Sub, change notifications, etc.) and submission review •&nbsp;&nbsp;&nbsp;&nbsp;Support regulatory agency and/or notified body audits by as needed •&nbsp;&nbsp;&nbsp;&nbsp;Participate in development and approval of risk activities as well as other deliverables as related to medical device projects •&nbsp;&nbsp;&nbsp;&nbsp;Review and approve all Labeling (product, advertising and promotional) and ensure claims are substantiated •&nbsp;&nbsp;&nbsp;&nbsp;Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders •&nbsp;&nbsp;&nbsp;&nbsp;Support customer inquiry related to compliance issues •&nbsp;&nbsp;&nbsp;&nbsp;Comply with Xylem Code of Ethics, all Company policies, rules, and proceduresRequired Qualifications: •&nbsp;&nbsp; &nbsp;Bachelor’s degree in a Science or Engineering field, or equivalent work experience •&nbsp;&nbsp; &nbsp;5+ years of Medical Device Regulatory Affairs experience, domestic and international •&nbsp;&nbsp; &nbsp;3 years of experience with Class II or III medical devices •&nbsp;&nbsp; &nbsp;Proven history of successful domestic and/or international submissions Preferred Qualifications: •&nbsp;&nbsp; &nbsp;Strong analytical and critical thinking skills •&nbsp;&nbsp; &nbsp;Strong verbal and writing communication skills •&nbsp;&nbsp; &nbsp;Ability to manage and prioritize multiple projects to meet deadlines that align with Xylem objectives •&nbsp;&nbsp; &nbsp;Proven track record of working as a team player to overcome obstacles and complete tasks through collaboration •&nbsp;&nbsp; &nbsp;Proficiency in MS Office software programsJoin the global Xylem team to be a part of innovative technology solutions transforming water usage, conservation, and re-use. Our products impact public utilities, industrial sectors, residential areas, and commercial buildings, with a commitment to providing smart metering, network technologies, and advanced analytics for water, electric, and gas utilities. Partner with us in creating a world where water challenges are met with ingenuity and dedication; where we recognize the power of inclusion and belonging in driving innovation and allowing us to compete more effectively around the world.<div>At Xylem, you'll not only contribute to solving water issues but also have the chance to make a difference through our paid Volunteer Program, Xylem Watermark. We prioritize our employees' well-being through inclusion and belonging as well as our Employee Resource Groups (ERG). Proud to be an Equal Employment Opportunity (including disability and veterans) and Affirmative Action workplace, Xylem fosters an inclusive environment free from discrimination or harassment.&nbsp;</div><div> &nbsp;</div><div>Please note that the information in this job description outlines the general nature of the position and is not an exhaustive list of duties. Xylem is dedicated to providing reasonable accommodations to enable all employees to perform their essential job functions. We reserve the right to modify this job description and assign additional duties as needed. Embrace the opportunity to be part of Xylem's transformative journey in shaping the future of water technology! #XylemCareers #GlobalImpact #WaterInnovation&nbsp;</div>

Senior Product Compliance Analyst

About the Job

About the Company

Xylem

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