Compliance Sme – Medical Device Software Job at Codvo AI

Senior Principal Business Analyst

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

United States , Bellevue

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

12+ years in Business Analyst or Inbound Product Manager roles with evidence of successful product delivery
BS/BA in an engineering discipline with software/project management focus preferred
healthcare or medical device experience preferred
Experience in full lifecycle technical product management, from ideation to delivery
Expertise in software development processes — Strong understanding of agile software development methodologies and lifecycle practices
Cross‑functional leadership — Demonstrated ability to build and leverage strategic relationships across diverse teams
Analytical and operational excellence — Proven track record of analytical rigor, detail orientation, and process discipline
Advanced communication skills — Skilled in verbal, written, and negotiation communication, including managing objections
Creative problem‑solving — Strong analytical and creative thinking with the ability to solve complex product and program challenges
Organizational strength — Highly organized, self‑directed, and effective at prioritizing in fast‑paced environments

Job Responsibility

Analyzing stakeholder needs — Partner with Product Management, Independent Diagnostic Testing Facility electrocardiogram (ECG) Technicians, Customer Experience, Finance, and IT to gather and clarify business needs
Defining requirements — Collect, analyze, and validate requirements for completeness, feasibility, and alignment with standards
Serving as a product SME — Provide subject‑matter expertise on product features, workflows, and system behavior throughout development and support
Translating concepts into specifications — Convert user needs into clear functional requirements and technical specifications for development teams
Modeling processes — Develop process maps, diagrams, and documentation to guide developers and project teams
Driving quality and efficiency — Create process documentation and work instructions that improve quality, consistency, and team performance
Leading testing activities — Build and execute test plans to identify issues early and ensure readiness before implementation
Supporting regulatory compliance — Assist technical teams in preparing documentation required for FDA and global regulatory standards

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Principal Business Analyst

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Bellevue

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

12+ years in Business Analyst or Inbound Product Manager roles with evidence of successful product delivery
BS/BA in an engineering discipline with software/project management focus preferred
healthcare or medical device experience preferred
Experience in full lifecycle technical product management, from ideation to delivery
Expertise in software development processes — Strong understanding of agile software development methodologies and lifecycle practices
Cross‑functional leadership — Demonstrated ability to build and leverage strategic relationships across diverse teams
Analytical and operational excellence — Proven track record of analytical rigor, detail orientation, and process discipline
Advanced communication skills — Skilled in verbal, written, and negotiation communication, including managing objections
Creative problem‑solving — Strong analytical and creative thinking with the ability to solve complex product and program challenges
Organizational strength — Highly organized, self‑directed, and effective at prioritizing in fast‑paced environments

Job Responsibility

Analyzing stakeholder needs
Defining requirements
Serving as a product SME
Translating concepts into specifications
Modeling processes
Driving quality and efficiency
Leading testing activities
Supporting regulatory compliance

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Principal Business Analyst

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

United States , Bellevue

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

12+ years in Business Analyst or Inbound Product Manager roles with evidence of successful product delivery
BS/BA in an engineering discipline with software/project management focus preferred
healthcare or medical device experience preferred
Experience in full lifecycle technical product management, from ideation to delivery
Expertise in software development processes
Strong understanding of agile software development methodologies and lifecycle practices
Cross-functional leadership
Demonstrated ability to build and leverage strategic relationships across diverse teams
Analytical and operational excellence
Proven track record of analytical rigor, detail orientation, and process discipline

Job Responsibility

Analyzing stakeholder needs
Defining requirements
Serving as a product SME
Translating concepts into specifications
Modeling processes
Driving quality and efficiency
Leading testing activities
Supporting regulatory compliance

What we offer

Medical and dental coverage
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off (20 to 35 days based on length of service)
Family and medical leaves of absence
Paid parental leave

Fulltime

Senior Principal Business Analyst

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

United States , Bellevue

Salary:

144000.00 - 198000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

12+ years in Business Analyst or Inbound Product Manager roles with evidence of successful product delivery
BS/BA in an engineering discipline with software/project management focus preferred
healthcare or medical device experience preferred
Experience in full lifecycle technical product management, from ideation to delivery
Expertise in software development processes — Strong understanding of agile software development methodologies and lifecycle practices
Cross‑functional leadership — Demonstrated ability to build and leverage strategic relationships across diverse teams
Analytical and operational excellence — Proven track record of analytical rigor, detail orientation, and process discipline
Advanced communication skills — Skilled in verbal, written, and negotiation communication, including managing objections
Creative problem‑solving — Strong analytical and creative thinking with the ability to solve complex product and program challenges
Organizational strength — Highly organized, self‑directed, and effective at prioritizing in fast‑paced environments

Job Responsibility

Analyzing stakeholder needs — Partner with Product Management, Independent Diagnostic Testing Facility electrocardiogram (ECG) Technicians, Customer Experience, Finance, and IT to gather and clarify business needs
Defining requirements — Collect, analyze, and validate requirements for completeness, feasibility, and alignment with standards
Serving as a product SME — Provide subject‑matter expertise on product features, workflows, and system behavior throughout development and support
Translating concepts into specifications — Convert user needs into clear functional requirements and technical specifications for development teams
Modeling processes — Develop process maps, diagrams, and documentation to guide developers and project teams
Driving quality and efficiency — Create process documentation and work instructions that improve quality, consistency, and team performance
Leading testing activities — Build and execute test plans to identify issues early and ensure readiness before implementation
Supporting regulatory compliance — Assist technical teams in preparing documentation required for FDA and global regulatory standards

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Senior Computer System Validation (CSV) Analyst

We are seeking a highly experienced and detail-oriented Senior Computer System V...

Location

India , Hyderabad

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field
12+ years of hands-on experience in Computer System Validation (CSV) in FDA-regulated industries (Pharmaceuticals, Biotechnology, or Medical Devices)
5+ years of extensive expertise in GAMP 5 methodology
Software Development Life Cycle (SDLC)
Risk-based validation approaches
Data integrity principles (ALCOA+)
FDA 21 CFR Part 11 and EU Annex 11
Proven experience leading validation projects and working in global, cross-functional teams

Job Responsibility

Lead the development, review, and approval of Validation Plans, URS, FS, DS, RTM, and Validation Summary Reports
Define and implement risk-based validation strategies aligned with GAMP 5
Establish and standardize validation documentation practices across projects and systems
Ensure all deliverables comply with GxP, FDA, and EU regulatory requirements
Oversee execution of IQ, OQ, PQ protocols, ensuring completeness, accuracy, and compliance
Provide technical leadership during validation activities and troubleshooting
Coordinate with IT, QA, Engineering, and business stakeholders to ensure timely delivery
Review and approve test scripts, execution results, and deviation reports
Act as a subject matter expert (SME) for FDA 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), GAMP 5 framework
Lead risk assessments (FMEA, risk ranking) to define validation scope and effort

Fulltime

Qms Engineer

This role will take the lead of Essilor Luxottica global quality system CAPAs (F...

Location

Thailand , Chonburi

Salary:

Not provided

OPSM

Expiration Date

Until further notice

Requirements

Bachelor / Master degree in Engineering or Science in the field of Chemistry / Material / Industrial / Physical / Electrical / Mechanical or its equivalent
Knowledge of quality system minimum requirement but not limit to: ISO13485, ISO9001, GMP and ISO14971
Enrich with quality mindset in Medical Devices or Healthcare environment and have systematic and logical thinking
Solid knowledge of Quality system (Document control, Quality audit, Management of change, Risk management, Software Validation and computerized systems compliance within a regulated environment, CAPA)
3-5 year of working experience in Essilor Luxottica or Globally organization is advantage
Project management skills and know- how will be an advantage
Proficient in MS Applications (Excel, Word, PowerPoint, SharePoint, Visio)
Proficient in English (read, write, speak) and may require to travel in the zone around 10-20%
Non-technical skill required
leadership, organization skills, clear and effective communication, logical thinking, action and result oriented ability to animate and mobilize the teams.

Job Responsibility

Lead the Global QMS CAPAs process and driving cross-function on global problems solving and process improvement related to quality system to ensure effective and sustainable quality practices
Acts as Subject Matter Expert (SME) for Software Validation, supporting the design, implementation and continuous improvement of global Software Validation process in alignment with ISO 13485, GMP and applicable regulatory expectations
Ensure Software Validation compliance is embedded into QMS processes, recognizing its critical role in audit readiness, regulatory inspections and operational continuity
Continue the maintenance and effectiveness of QMS implementation based on Essilor Luxottica Group Quality System and related quality standard requirement
Organize and perform quality audits to assess compliance and identify areas for improvement, ensuring readiness for audits by Certification Bodies and competent Authorities and ensure quality system comply with Essilor Luxottica group quality system and related quality standard requirement
Follow up, monitor CAPAs WW (CAPAs from global Audits, Certification Audits, Competent Authorities Inspections, etc.), and leverage effective solutions for global deployment
Promote and establish a continuous improvement culture by initiate and leading global quality project to enhance and harmonize QMS workflows in alignment with Medical Device Regulations, and promote the culture of “Find it once, fix it everywhere”
Collaborate with global stakeholders to embed quality into core operations and drive strategic alignment across each area and functions.

Compliance Engineer

The Compliance Engineer will work with software development teams to ensure all ...

Location

United States , San Diego

Salary:

91000.00 - 113000.00 USD / Year

ResMed

Expiration Date

Until further notice

Requirements

BS/MS in any engineering discipline. Computer science preferred
No hands-on coding experience is needed
Working knowledge of regulations including but not limited to MDSAP, ISO13485:2016, IEC62304, SOC2 controls
3 years of experience delivering medical products and navigating through audits like MDR, SOC2, MDSAP, HDS, or any other regulatory framework is a plus
Proficiency in report writing, analysis, and compliance procedures
Thorough understanding of regulatory frameworks
Solid technical knowledge and understanding of Software Product Life Cycle (SDLC)

Job Responsibility

Act as SME for all the audits for ResMed's digital products. Represent ResMed Engineering in audits, including but not limited to HDS, MDSAP, SOC2, and MDR
Identify and evaluate technical design alternatives to achieve desired functionality in partnership with cross-functional team members and Systems Architecture Leaders
Educate the engineering teams on the design review needs and facilitate the design review process among those teams
Enhance or modify existing design review processes
Help resolve technical issues
Drive the bug-triage process and help determine issues that impact patient safety
Participate in the product roadmaps and influence the release of features based on safety risk analysis
Act as a bridge between Product Engineering and ResMed Quality/Regulatory teams and bring knowledge on the latest safety-related standards
Tackle intrinsically challenging problems with implication to regulatory requirements from around the world
Ensure the company's technical compliance with applicable laws and regulations

What we offer

comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Fulltime

Design Control Engineer

The Design Controls Engineer (L5) will be the centralized owner of Dandy’s desig...

Location

United States

Salary:

101150.00 - 119000.00 USD / Year

Dandy

Expiration Date

Until further notice

Requirements

3+ years of experience in medical devices / life sciences with deep focus on design controls, V&V, and risk management (startup/scale-up experience strongly preferred)
Proven track record building and operating design control frameworks in environments where development is distributed across multiple teams
Strong working knowledge of: ISO 13485 (design & development controls, design changes)
FDA 21 CFR 820 design controls expectations
ISO 14971 risk management
IEC 62304 software lifecycle evidence (where applicable)
Demonstrated ability to lead cross-functional design reviews, drive decisions, and create audit-ready DHFs/RMFs
Excellent technical writing and documentation discipline
able to translate requirements into pragmatic templates and checklists teams will actually use
20% domestic travel

Job Responsibility

Build and own design controls execution (HW + SW)
Establish and maintain Dandy’s Design & Development procedures (ISO 13485 §7.3) and supporting templates: Design Plans, Design Inputs/Outputs, Design Reviews, V&V plans, and DHF structures for both hardware and software
Define a scalable DHF / design evidence model that fits Dandy’s distributed development structure and multi-site operations
Design-change impact assessment (within QMS change control)
For every relevant change (software feature release, hardware/material spec change, packaging change, labeling/IFU change), own the design-change impact assessment: what DHF/RMF/traceability/V&V updates are required and what evidence must be created
Ensure design-change work is executed through the established QMS change control workflow, including proper linkage to controlled documents, records, and training impacts where applicable
Partner closely with Regulatory and Quality to flag when design changes may affect regulatory commitments and require additional documentation or testing
Drive risk management integration
Drive risk management activities per ISO 14971, integrating hazard analysis, FMEAs, and risk controls with verification evidence and traceability
Ensure risk files are current and connected to design decisions, design reviews, and releases

What we offer

healthcare
dental
mental health support
parental planning resources
retirement savings options
generous paid time off

Fulltime

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Compliance Sme – Medical Device Software

Job Description

Job Responsibility

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