Compliance Engineer Job at ElevenLabs (Tokyo)

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Compliance Engineer

The Product Compliance Engineer will partner with global product developers and ...

Location

United States , Needham

Salary:

72700.00 - 111400.00 USD / Year

SharkNinja

Expiration Date

Until further notice

Requirements

Bachelor's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Computer Science, or a related technical discipline
RAC certification a plus
Minimum 2–4 years of compliance or design-related experience with consumer, commercial, or medical electromechanical products
Working knowledge of medical device regulatory standards including: IEC 60601-1 and applicable collateral/particular standards (esp. IEC 60601-1-2 for EMC, IEC 60601-1-6 for usability, IEC 60601-1-11 for home healthcare environments)
ISO 14971 – Risk Management for Medical Devices
ISO 13485 – Quality Management Systems
IEC 62366-1 – Usability Engineering
IEC 62304 – Medical Device Software Lifecycle (where applicable)
ISO 10993 series – Biocompatibility Evaluation
21 CFR Part 820 – FDA Quality System Regulation

Job Responsibility

Support the execution of certification activities and risk analysis for multiple new product development projects, including FDA-regulated medical devices and products subject to EU MDR 2017/745
Assist in preparing regulatory filings including FDA 510(k) submissions and Technical Files/Design Dossiers, and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design Controls and ISO 13485 requirements
Support the establishment of project needs and deliverables for both product development teams and third-party regulatory partners, including Notified Bodies and FDA-accredited testing laboratories
Execute risk management activities in accordance with ISO 14971
Support usability engineering processes per IEC 62366-1
Evaluate project risk during the development process and support contingency planning
Participate in weekly reviews for all assigned projects
Assure that all activities related to product certification commence and execute as planned and on schedule
Support product development teams as a subject matter expert
Contribute to intradepartmental continuous improvement and special projects

What we offer

Medical insurance
dental insurance
vision insurance
flexible spending accounts
health savings accounts (HSA) with company contribution
401(k) retirement plan with matching
employee stock purchase program
life insurance
AD&D
short-term disability insurance

Fulltime

Compliance Engineer

About ElevenLabs ElevenLabs is an AI research and product company transforming ...

Location

United States , New York

Salary:

Not provided

ElevenLabs

Expiration Date

Until further notice

Requirements

Experience in completing vendor security assessments and client security questionnaires in highly regulated industries, such as Government and Defense in the US
Strong technical expertise in managing and executing compliance, with hands-on experience using compliance management tools (e.g. Vanta)
Proven ability to maintain and acquire certifications while managing audit readiness and documentation
Experience collaborating with cross-functional teams (sales, engineering, legal) to effectively communicate compliance requirements and ensure smooth operations
Experience with public cloud compliance (AWS, GCP, Azure) and automating compliance in cloud environments
Familiarity with integrating compliance tools into CI/CD pipelines to automate monitoring and reporting

Job Responsibility

Collaborating across teams to maintain US Government compliance certifications and frameworks such as GovRAMP, FedRAMP, CJIS and CMMC
Helping to shape ElevenLabs’ Enterprise offering towards regulated industries such as Local and State Government, Defense and Finance
Building technical documentation to demonstrate our compliance to our customers throughout the stack
Assisting the sales team by responding to client security requests and managing compliance-related queries
Conduct risk assessments based on CIS or NIST frameworks, document findings, and help teams achieve compliance efficiently
Enhance compliance as code tooling to automate monitoring, reporting, and reduce friction for other teams to remain compliant

What we offer

Innovative culture
Growth paths
Learning & development through an annual discretionary stipend
Social travel through an annual discretionary stipend
Annual company offsite
Co-working stipend if not located near a main hub

Fulltime

Compliance Engineer

An exciting opportunity has now arisen within PAM Ireland for a Compliance Engin...

Location

Ireland , Shannon

Salary:

Not provided

Ryanair - Europe's Favourite Airline

Expiration Date

Until further notice

Requirements

Basic understanding of EASA & UK regulations relating to maintenance, operation, engineer licencing & certification
Experience of working in an Aircraft/Component Maintenance Organisation
Basic understanding of Aircraft/Component Maintenance Organisation quality related processes and procedures
Basic understanding of quality and continuous improvement tools/techniques
The ability to adapt to change quickly with a can-do attitude
Ability to plan and work to deadlines on own initiative
Willingness to travel within UK and Europe
Excellent Interpersonal skills
MS Office/Smartsheet experience

Job Responsibility

Ensuring that policies, procedures and processes are aligned with regulatory and customer requirements
Carrying out independent quality audits of the Facilities, Procedures, Vendors and Airworthiness Standards of the organisation in accordance with an audit programme devised by the CMM
Maintaining knowledge of maintenance requirements and standards, and the requirements for PART-145 Approval, to the extent necessary to ensure that audits are effective and comprehensive
Completing Non-Conformity Reports for each area or aspect of the organisation’s maintenance activity which has been audited and where non-compliance with PART 145, the MOE or Technical Procedures are identified, submitting these to the responsible person. Supporting the closure of Non-Conformance Report
Assessment of regulatory requirements to ensure as a minimum compliance is maintained
Working with all value streams within the business to support change
Support various compliance related activities including continuous improvement activities across all sites

What we offer

Permanent contract
Significant training opportunities including individual on the job training programme
Competitive salary in accordance with experience
Be part of a growing team with opportunities for travel to bases across Europe

Fulltime

Compliance Engineer

About the role: Compliance Engineer - US. About ElevenLabs: ElevenLabs is an AI ...

Location

United States , New York

Salary:

Not provided

ElevenLabs

Expiration Date

Until further notice

Requirements

Experience in completing vendor security assessments and client security questionnaires in highly regulated industries, such as Government and Defense in the US
Strong technical expertise in managing and executing compliance, with hands-on experience using compliance management tools (e.g. Vanta)
Proven ability to maintain and acquire certifications while managing audit readiness and documentation
Experience collaborating with cross-functional teams (sales, engineering, legal) to effectively communicate compliance requirements and ensure smooth operations
Experience with public cloud compliance (AWS, GCP, Azure) and automating compliance in cloud environments
Familiarity with integrating compliance tools into CI/CD pipelines to automate monitoring and reporting

Job Responsibility

Collaborating across teams to maintain US Government compliance certifications and frameworks such as GovRAMP, FedRAMP, CJIS and CMMC
Helping to shape ElevenLabs’ Enterprise offering towards regulated industries such as Local and State Government, Defense and Finance
Building technical documentation to demonstrate our compliance to our customers throughout the stack
Assisting the sales team by responding to client security requests and managing compliance-related queries
Conduct risk assessments based on CIS or NIST frameworks, document findings, and help teams achieve compliance efficiently
Enhance compliance as code tooling to automate monitoring, reporting, and reduce friction for other teams to remain compliant

What we offer

Innovative culture
Growth paths
Learning & development: ElevenLabs proactively supports professional development through an annual discretionary stipend
Social travel: We also provide an annual discretionary stipend to meet up with colleagues each year, however you choose
Annual company offsite
Co-working: If you’re not located near one of our main hubs, we offer a monthly co-working stipend

Fulltime

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

Compliance Engineer

As a Compliance Engineer, you will help our engineers implement Palantir Securit...

Location

United States , Washington, D.C.

Salary:

90000.00 - 150000.00 USD / Year

Palantir Technologies

Expiration Date

Until further notice

Requirements

3+ years experience with compliance (PCI, SOC2, HIPAA, etc.) with at least 2 years related to US Government compliance and audit experience (e.g FedRAMP, IL5, CMMC, FISMA, NIST 800-53, etc.)
Deep understanding of cloud infrastructure and security concepts
Experience with distributed applications on cloud infrastructure (AWS, Azure, GCP)
Familiarity with security controls for cloud automation and configuration tooling (Terraform, Puppet, Jenkins, etc.)
Ability to clearly communicate compliance requirements to internal engineering teams and associated implementation to external customers
Proficiency with security concepts (encryption, authentication, etc.) and tooling for continuous monitoring (Tenable, Splunk, etc.)
Hands-on experience in executing against recurring operational regulatory requirements
Strong attention to detail
Willingness and eligibility to obtain a U.S. security clearance

Job Responsibility

Implement all aspects of US Government compliance, including FedRAMP, IL5, and IL6 continuous monitoring and compliance audits
Support partnerships with various agencies (DoD, HHS, etc.), 3PAOs, and the FedRAMP PMO
Partner with engineers to interpret and map compliance requirements to product implementation
Directly facilitate operational and regulatory outcomes, including continuous monitoring and compliance audits
Build automation for procedural compliance controls
Guide technical and operational decision-making towards future product offerings and efficient organizational processes

What we offer

Medical, dental, and vision insurance
Voluntary life insurance
Basic life, AD&D and disability insurance
Commuter benefits
Take what you need paid time off
2 weeks paid time off built into the end of each year
10 paid holidays
Supportive leave of absence program
Paid leave for new parents
Subsidized back-up care for all parents

Fulltime

Compliance Engineer

As a Compliance Engineer, you will help our engineers implement Palantir Securit...

Location

United States , Palo Alto

Salary:

90000.00 - 150000.00 USD / Year

Palantir Technologies

Expiration Date

Until further notice

Requirements

Willingness and eligibility to obtain a U.S. security clearance
3+ years experience with compliance (PCI, SOC2, HIPAA, etc.) with at least 2 years related to US Government compliance and audit experience (e.g FedRAMP, IL5, CMMC, FISMA, NIST 800-53, etc.)
Deep understanding of cloud infrastructure and security concepts
Experience with distributed applications on cloud infrastructure (AWS, Azure, GCP)
Familiarity with security controls for cloud automation and configuration tooling (Terraform, Puppet, Jenkins, etc.)
Ability to clearly communicate compliance requirements to internal engineering teams and associated implementation to external customers
Proficiency with security concepts (encryption, authentication, etc.) and tooling for continuous monitoring (Tenable, Splunk, etc.)
Hands-on experience in executing against recurring operational regulatory requirements
Strong attention to detail

Job Responsibility

Implement all aspects of US Government compliance, including FedRAMP, IL5, and IL6 continuous monitoring and compliance audits
Support partnerships with various agencies (DoD, HHS, etc.), 3PAOs, and the FedRAMP PMO
Partner with engineers to interpret and map compliance requirements to product implementation
Directly facilitate operational and regulatory outcomes, including continuous monitoring and compliance audits
Build automation for procedural compliance controls
Guide technical and operational decision-making towards future product offerings and efficient organizational processes

What we offer

Employees (and their eligible dependents) can enroll in medical, dental, and vision insurance as well as voluntary life insurance
Employees are automatically covered by Palantir’s basic life, AD&D and disability insurance
Commuter benefits
Take what you need paid time off, not accrual based
2 weeks paid time off built into the end of each year (subject to team and business needs)
10 paid holidays throughout the calendar year
Supportive leave of absence program including time off for military service and medical events
Paid leave for new parents and subsidized back-up care for all parents
Fertility and family building benefits including but not limited to adoption, surrogacy, and preservation
Stipend to help with expenses that come with a new child

Fulltime

Compliance Engineer

As a Compliance Engineer, you will help our engineers implement Palantir Securit...

Location

United States , New York

Salary:

90000.00 - 150000.00 USD / Year

Palantir Technologies

Expiration Date

Until further notice

Requirements

3+ years experience with compliance (PCI, SOC2, HIPAA, etc.) with at least 2 years related to US Government compliance and audit experience (e.g FedRAMP, IL5, CMMC, FISMA, NIST 800-53, etc.)
Deep understanding of cloud infrastructure and security concepts
Experience with distributed applications on cloud infrastructure (AWS, Azure, GCP)
Familiarity with security controls for cloud automation and configuration tooling (Terraform, Puppet, Jenkins, etc.)
Ability to clearly communicate compliance requirements to internal engineering teams and associated implementation to external customers
Proficiency with security concepts (encryption, authentication, etc.) and tooling for continuous monitoring (Tenable, Splunk, etc.)
Hands-on experience in executing against recurring operational regulatory requirements
Strong attention to detail
Willingness and eligibility to obtain a U.S. security clearance

Job Responsibility

Implement all aspects of US Government compliance, including FedRAMP, IL5, and IL6 continuous monitoring and compliance audits
Support partnerships with various agencies (DoD, HHS, etc.), 3PAOs, and the FedRAMP PMO
Partner with engineers to interpret and map compliance requirements to product implementation
Directly facilitate operational and regulatory outcomes, including continuous monitoring and compliance audits
Build automation for procedural compliance controls
Guide technical and operational decision-making towards future product offerings and efficient organizational processes

What we offer

Employees (and their eligible dependents) can enroll in medical, dental, and vision insurance as well as voluntary life insurance
Employees are automatically covered by Palantir’s basic life, AD&D and disability insurance
Commuter benefits
Take what you need paid time off, not accrual based
2 weeks paid time off built into the end of each year (subject to team and business needs)
10 paid holidays throughout the calendar year
Supportive leave of absence program including time off for military service and medical events
Paid leave for new parents and subsidized back-up care for all parents
Fertility and family building benefits including but not limited to adoption, surrogacy, and preservation
Stipend to help with expenses that come with a new child

Fulltime

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