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 23000 employees operating in over 150 countries Xylem is at the forefront of addressing the worlds 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 Analystwill 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 Analystwill 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 procedures

Required Qualifications:

Bachelors 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 programs

Join 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.