Documentation Control Specialist EDA StaffingDocumentation Control SpecialistBeverly, MA$55,000–$65,000 / yearFull timeThis position works closely with Engineering, Manufacturing, Operations, and Quality teams to ensure documentation, training records, regulatory requirements, and quality processes remain accurate, compliant, and audit-ready. We are seeking a Document Control & Regulatory Compliance Specialist to play a key role in maintaining and improving our Quality Management System (QMS).
NewPayroll Specialist Vaco LLCPayroll SpecialistBoston, MA$35–$40Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewAccounts Payable Specialist Vaco LLCAccounts Payable SpecialistAndover, MA$60,000–$65,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewContracts and Compliance Specialist GCR Professional ServicesContracts and Compliance SpecialistAyer, Massachusetts$98,000–$100,000 / yearThe Contracts & Compliance Specialist will manage the full lifecycle of government and commercial contracts while ensuring compliance with FAR, DFARS, ITAR, and other applicable regulations. This role is critical to minimizing risk, maintaining contractual integrity, and supporting operations within a highly regulated environment.
NewCollections Specialist Vaco LLCCollections SpecialistNorth Andover, MA$47,840–$49,920We've partnered with our client to find a Collections Specialist to join a dynamic team and make a meaningful impact every day. ResponsibilitiesReview and document account status; contact customers regarding delinquent loansPrepare and send correspondence for accounts requir...
NewSenior Payroll Specialist Vaco LLCSenior Payroll SpecialistFramingham, MA$80,000–$90,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewFood Safety Specialist Global PartnersFood Safety SpecialistWaltham, MA$66,600–$93,200Assist stores in obtaining and maintaining their regulatory compliance with Food Safety Manager certifications (ANSI approved and accredited), Food Handler, Allergen Awareness and other locally required food safety related certifications. The final amount offered at the start of employment is determined based on factors including, but not limited to, experience level, knowledge, skills, abilities and geographic location, and the Company reserves the right to modify base salary at any time, including for reasons related to individual performance, Company or individual department/team performance and market factors.
Recovery Specialist - Case Management - 6 TalentBurst, Inc.Recovery Specialist - Case Management - 6Danvers, MA$25–$26 / hourEssential Functions/Key Responsibilities: Responsible for maintaining individual case load, which involves conducting individual intake evaluations, treatment and aftercare planning, medication management support, and safety planning as needed. This includes assessing service needs; counseling, developing plans for access to services, liaison with client, families, programs, and service providers.
NewEquipment Specialist, Senior - Secret DCS CorporationEquipment Specialist, Senior - SecretBedford, MA$90,220–$130,000 / yearSupport configuration control by processing, tracking, and recommending dispositions for change notices, ecps, deviation/waiver requests, service bulletins, deficiency reports, Airworthiness Directive Notes, and qcps. Provide integrated logistics support, including provisioning, source coding, maintenance data collection, configuration management data, QDR analysis, and identifying alternate sources of supply for DMS/MS issues.
TECH SVCS - IT Lab Computing Support Specialist ECLAROTECH SVCS - IT Lab Computing Support SpecialistDevens, MA$43.27–$45.90 / hourMinimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting. Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.
Customer Support Specialist Wakefield Thermal Solutions, Inc.Customer Support SpecialistNashua, NHAdminister and manage key business processes for assigned customer accounts, including quotations, sample and prototype coordination, pre-production, production, order management, quality support, and ongoing customer service. Building on over four decades of leadership and experience, Wakefield Thermal designs, manufactures, and sells thermal management products that remove excess heat generated by electronic components.
NewIndirect Sourcing Specialist – Facilities/ Global Operations # 26-15153 US Tech Solutions, Inc.Indirect Sourcing Specialist – Facilities/ Global Operations # 26-15153Marlborough, MAThe incumbent will manage a broad portfolio of services including managed facility services, security services and construction services to achieve sustainable cost reductions, mitigate supply chain risk and drive overall business objectives. Purpose StatementAs a core member of the Indirect Sourcing team, the Indirect Sourcing Specialist leads the development and execution of sourcing strategies for assigned categories within Global Facilities that supports worldwide operations.
NewRisk Assessment / Technical Document Specialist- #26-15672 US Tech Solutions, Inc.Risk Assessment / Technical Document Specialist- #26-15672Lexington, MAPrimary Duties:This contractor role is responsible for modernizing technical system documentation across Quality Control Lab Systems and performing structured data integrity risk assessments to enable risk-based optimization of procedural controls. Apply global Quality Risk Management (QRM) / ICH Q9 principles to evaluate data integrity controls such as audit trail review, backup/restore verification, and user access management.
NewSr. Desktop Support Specialist Bluestone BankSr. Desktop Support SpecialistRaynham, MA$29–$32 / hourProvides advanced assistance and support to users for routine and complex telephone equipment issues, printer and copy machine support, bank email system(s) support, general file access administration, and workstation software/hardware support, including repair, moves, installations, deployments, and upgrades. Completes the IT daily checklist in the absence of the Senior Systems Administrator, including validation of nightly server backups, antivirus updates, Windows and non-Windows updates, server capacity status, secure email, and other operating system updates.
NewClinical Practice Specialist Dana-Farber Cancer InstituteClinical Practice SpecialistCambridge, MA$129,800–$148,400 / yearWe strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.
NewProfessional Development Specialist-2 Dana-Farber Cancer InstituteProfessional Development Specialist-2BOSTON, MA$113,200–$133,800 / yearSupports nurses in the management of symptom distress related to cancer and/or its treatment based on advanced knowledge of the etiology of cancer, the rationale for treatment, patient and family responses and needs, and associated nursing interventions. Demonstrates expertise in areas of oncology clinical practice, by participating in patient care to identify opportunities for improvement, assess staff performance, and facilitate implementation of new practices.
NewProfessional Development Specialist-1 Dana-Farber Cancer InstituteProfessional Development Specialist-1BOSTON, MA$113,200–$133,800 / yearSupports nurses in the management of symptom distress related to cancer and/or its treatment based on advanced knowledge of the etiology of cancer, the rationale for treatment, patient and family responses and needs, and associated nursing interventions. Demonstrates expertise in areas of oncology clinical practice, by participating in patient care to identify opportunities for improvement, assess staff performance, and facilitate implementation of new practices.
Risk Management and Policy Specialist EclaroRisk Management and Policy SpecialistCanton, MAFull timeUpgrade current WISP to latest version of NIST800-53v5:Continue evaluation comparison of current WISP which is at NIST800-53v4 to newer NIST800-53v5. ECLARO's client is a market-leading insurance company, providing property, casualty, and specialty insurance services within the United States.
Regulatory Affairs Specialist CareerscapeRegulatory Affairs SpecialistBoston, MA$90,000–$125,000 / yearFull timeOur client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.
Senior Regulatory Affairs Specialist Dentsply Sirona IncSenior Regulatory Affairs SpecialistMAFor California Residents: We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).
Senior Regulatory Affairs Specialist Smith & Nephew PlcSenior Regulatory Affairs SpecialistMansfield, MA$101,500–$152,250 / yearThe anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate's qualifications, job-related knowledge/skills, geographical location. Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Regulatory Affairs Specialist Dentsply Sirona IncRegulatory Affairs SpecialistMADentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Key Responsibilities: Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistMA$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. • Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
Usability and Regulatory Affairs Specialist SentecUsability and Regulatory Affairs SpecialistLincoln, RI$80,000–$100,000Develop and maintain usability engineering documentation, including use specifications, task analyses, use-related risk analyses, and the usability engineering file, in accordance with IEC 62366 and FDA guidance. You will work closely with engineering, clinical, and quality teams to identify and mitigate use-related risks—ultimately helping bring high-impact medical technologies to market.
Senior International Regulatory Affairs Specialist Butterfly NetworkSenior International Regulatory Affairs SpecialistBurlington, MAThis role requires a strong ability to translate evolving regulatory requirements—such as EU MDR 2017/745—into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles. In addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond.
Senior International Regulatory Affairs Specialist Butterfly Network IncSenior International Regulatory Affairs SpecialistBurlington, MAThis role requires a strong ability to translate evolving regulatory requirementssuch as EU MDR 2017/745into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles. In addition to its medical imaging products, Butterfly Embedded is the Companys Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond.
NewSenior Specialist, Regulatory Affairs Zoll Data Systems, Inc.Senior Specialist, Regulatory AffairsMARemote$101,600–$152,400 / yearSupport a culture of continuous improvement by promoting best practices, fostering innovation, and recognizing and celebrating achievements as well report on key performance indicators (KPIs) to track the progress and impact of continuous improvement efforts. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
Regulatory Affairs Specialist Hologic IncRegulatory Affairs SpecialistMarlborough, MAOur Regulatory Affairs team plays a vital role in bringing innovative compliant and safe medical technologies to market helping advance early detection diagnosis and treatment solutions that improve the lives of women around the world. Hologic is seeking aRegulatory Affairs Specialistresponsiblefor assisting in the management of all regulatory activities within the defined countrygeographical areas by performing the following under supervision of RA management or more senior RA personnel.
Regulatory Specialist Canadian Nuclear Laboratories LtdRegulatory SpecialistBurlington, MARemoteFrom building the next generation of clean nuclear and hydrogen energy technologies, to developing targeted cancer treatments, to continuing our global leadership in environmental remediation-we are driven by impact, innovation, and purpose. Bachelor''s (Honours) or Master''s or PHD in Engineering or Science from a university of recognized standing; OR membership in an engineering or scientific professional organization authorized by statute to establish qualification for membership in that organization.
Regulatory Affairs Specialist LGC LtdRegulatory Affairs SpecialistMilford, MAOur integrated portfolio of products, services and expertise supports our purpose of Science for a Safer World and we have embodied our mission by working with customers to enable research into life-altering treatment for disease and illness worldwide. LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, parental responsibilities, religion, or belief.
Regulatory & Clinical Specialist LivaNova PlcRegulatory & Clinical SpecialistBoston, MARemote$85,000–$95,000 / yearManage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members. The Regulatory and Clinical Specialist is a liaison with the organization working with various groups to effectively communicate and collaborate on the deliverables and meet the project deadlines in line with the regulatory requirements.
Senior Regulatory Affairs Program Specialist Zoll Data Systems, Inc.Senior Regulatory Affairs Program SpecialistChelmsford, MARemoteThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Senior Regulatory Affairs Program Specialist ZOLL MedicalSenior Regulatory Affairs Program SpecialistChelmsford, MassachusettsRemoteThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Essential FunctionsEvaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Asset and Wealth Management External Audit - Regulatory Reporting Specialist - Director PricewaterhouseCoopers LLPAsset and Wealth Management External Audit - Regulatory Reporting Specialist - DirectorMA$134,000–$348,500 / yearAs an Asset and Wealth Management External Audit - Regulatory Reporting Specialist - Director, you will play a pivotal role in guiding clients through complex regulatory landscapes, enhancing their internal controls, and mitigating risks effectively. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
Regulatory Compliance Specialist II Expert In Recruitment SolutionsRegulatory Compliance Specialist IICambridge, MAThe RSO Specialist, manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, specific country documentation, and Annual reports. The RSO Specialist may represent RSO on M&S and MSAT project teams when product or valence-related regulatory site expertise is required and serve as the Regulatory interface between M&S, MSAT and GRA.
Principal Specialist - Regulatory Affairs & Compliance Gorton'sPrincipal Specialist - Regulatory Affairs & ComplianceGloucester, MassachusettsMonitor and evaluate emerging regulatory trends, enforcement actions, recalls, and global food safety risks to proactively manage regulatory risks and ensure company strategies remain aligned with current and future compliance requirements. - Provide technical expertise to support Gorton’s businesses in all areas related to ingredients, labeling and claims, legal, governmental and regulatory issues, including FDA registration requirements.
Regulatory Reporting & Compliance Specialist (Hybrid) American Family Insurance GroupRegulatory Reporting & Compliance Specialist (Hybrid)Boston, MA$62,000–$103,000 / yearAdditional Preferred Qualifications: Ability to translate reporting requirements into controlled, repeatable workflows using SQL/BigQuery, Excel, and work-tracking tools (e.g., Jira), with strong documentation to enhance operational efficiency and transparency. Work closely with regulators, states, boards, bureaus, vendors and stat agents related to new and existing regulations, new product, state development, legacy retirements, new data source development.
NewRegulatory Reporting & Compliance Specialist American Family InsuranceRegulatory Reporting & Compliance SpecialistBoston, MA$62,000–$103,000 / yearAdditional Preferred Qualifications: Ability to translate reporting requirements into controlled, repeatable workflows using SQL/BigQuery, Excel, and work-tracking tools (e.g., Jira), with strong documentation to enhance operational efficiency and transparency. Work closely with regulators, states, boards, bureaus, vendors and stat agents related to new and existing regulations, new product, state development, legacy retirements, new data source development.
NewFinancial Crime Risk Specialist - Regulatory Response & Audit Oversight The Toronto-Dominion BankFinancial Crime Risk Specialist - Regulatory Response & Audit OversightBoston, MA$91,000–$145,600 / yearTotal Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition. Employee/Team Accountabilities: Participates fully as a member of the team, supports a positive work environment that promotes service to the business, quality, innovation and teamwork and ensure timely communication of issues / points of interest.
NewPermitting & Regulatory Compliance Specialist II Core States GroupPermitting & Regulatory Compliance Specialist IIBurlington, MARemoteHEALTHCARE - Competitive health benefits including HSA with employer contribution, life insurance options, and supplemental coverage options, giving you the flexibility to select the coverage that best fits your needs and lifestyle. Core States Group designs, builds, and manages programs and projects across North America and has been recognized on top lists throughout the architecture, engineering, and construction (A/E/C) industry.
Manager, Regulatory Affairs LeMaitreManager, Regulatory AffairsBurlington, Massachusetts$110,000–$150,000 / yearFull timeProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.
Senior Regulatory Affairs Consultant - Regulatory Intelligence (Talent Pool) Parexel International CorpSenior Regulatory Affairs Consultant - Regulatory Intelligence (Talent Pool)MALead the client's internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities. In this consultative role, you will combine regulatory expertise, analytical rigor, and strong project leadership skills to navigate an evolving regulatory landscape while collaborating closely with clients, internal experts, and global teams.
Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, IncDirector, Regulatory Affairs – Global Regulatory StrategyBoston, MassachusettsFull timeOverview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
Sr. Regulatory Affairs Spclst RadNet IncSr. Regulatory Affairs SpclstSomerville, MAQualifications include: • Bachelor's degree in relevant field (or equivalent experience) • 8 - 12 years working in a regulated industry (FDA and Software as a Medical Device preferred) • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Regulatory Affairs Specialist, this position will: • Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineBoston, MA$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Manager, Regulatory Affairs LeMaitre Vascular IncManager, Regulatory AffairsBurlington, MA$110,000–$150,000 / yearProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
Senior Manager, Regulatory Affairs NAM Straumann Holding AGSenior Manager, Regulatory Affairs NAMMAThis role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.
Sr Regulatory Affairs Spec Medtronic PlcSr Regulatory Affairs SpecBoston, MAThis role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Sr. Regulatory Affairs Spclst DeephealthSr. Regulatory Affairs SpclstSomerville, Massachusetts$120,000–$165,000 / yearFull timeRegulatory Affairs Specialist, this position will: · Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. · Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.