57 applicants
Net Health · 2 days ago
Product Compliance Analyst II - Wound Care
Pittsburgh, PA
Full-time
Remote
Mid Level
4+ years exp
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Hiring Manager
Ashley Laux-Shaner
Insider Connection @Net Health
Responsibilities
Raise and maintain product compliance awareness to development/product team key stakeholders
Understand regulatory governing bodies and wound care product requirements such as the CMS (legal medical record: authentication; authorship integrity), Joint Commission Standards (or like non-profit healthcare accrediting organizations.), OIG, and OCR.
Ability to demonstrate thorough understanding of compliance related projects (governing requirements) to full product execution with all key stakeholders.
Will act as a SME key decision maker with wound care product/development team members in order to ensure compliance requirements are being met during the refinement process through release readiness.
Provides audits and reviews for the wound care product related to ICD-10, CPT4, NCCI
Understand regulatory governance for E-prescribing
Prepares regulatory updates related to wound care in conjunction with the project team
Articulate the value add to all related compliance projects that will resonate with our internal team stakeholders and customers
Ensure awareness and operational adherence to compliance-related product changes that impact patient safety, coding and billing, and/or other regulatory governing topics.
Support a proactive approach toward investigation and resolving potential product compliance issues
Understand and identify when compliance related topics may require additional support/investigation
Educate and inform all collaborative teams when specific features require additional research and scrutiny to adhere with compliance best practices
Support key information with prioritizing compliance stories, defects, and requirements in the shared backlog related to compliance.
Explore and attend employee development opportunities to enhance knowledge base regarding compliance topics such as coding/billing, CMS, Legal Medical Record, OIG, NHPCO, etc.,)
Actively utilize available resources by reviewing following updates/newsfeeds regarding compliance topics that may impact the product (technical updates, etc.,)
Establish and maintain regulatory policies with particular emphasis on compliance with the Quality Management System, and relevant Medical Device Directives and Regulations (e.g., ISO 13485).
Maintain existing device certifications (FDA Class I medical device, CE Mark, WAND)
Manage preparation for all regulatory body audits
Work across departments to achieve goals relative to regulatory compliance, including working with product development, HR, legal, and security
Manage and maintain the quality systems and any other quality-related activity
Provide regulatory guidance to product development team
Monitor global regulatory developments affecting products and communicate significant issues to management
Develop and implement all training required for regulatory compliance, including requirements related to device quality, defect reporting and communication of client requirements
Serve as point of contact for certification bodies and escalated client complaints
Identify and suggest solutions to regulatory tasks
Collaborate with consultants to prepare document packages for new device applications (FDA De Novo, MDSAP)
Report on QMS performance to ensure that quality objectives are met
Qualification
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Required
Bachelor’s degree in nursing, physical therapy, occupational therapy, law, healthcare administration or a related field of study
4+ years of experience working within healthcare compliance required (wound care compliance and CEHRT preferred)
Ability to read, understand, and interpret regulatory rules and requirements for a variety of audiences
Highly analytical with strong attention to detail
Outstanding written and verbal communication skills required (including the ability to express oneself effectively within groups and in one-to-one conversations)
Conveys information clearly and effectively in written and oral communication
Legal and/or compliance certification(s) preferred, i.e., (HCCA, IAPP, etc.)
Experience working in an entrepreneurial, fast-paced company
Self-directed and solution oriented
Maintain a high level of work effort consistency and follow through with all projects
Preferred
Experience in risk management or regulatory audit in the health care space, preferred
Benefits
Unlimited PTO
Comprehensive Benefits Package
Employee Resource Groups
Casual Dress Code
Prioritized Employee Wellness
Diversity And Inclusion
A Voice
New Hire Support
Career Development
Educational Assistance
Employee Referral Bonus
Progressive Parental Leave
Company
Net Health
Net Health provides cloud-based software for specialty medical providers across the continuum of healthcare—from hospital to home.
501-1,000 employees
H1B Sponsorship
Net Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (5)
2022 (7)
2021 (4)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
unknown2018-01-01Private Equity· Undisclosed
2017-12-18Acquired· by The Carlyle Group
Leadership Team
Ron Books
Chief Executive Officer
Gabe Hesse
Chief Technology Officer
Recent News
Company data provided by crunchbase
