Job Description : We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will involve working closely with cross-functional teams to ensure compliance with regulatory standards, preparing regulatory submissions, and providing strategic regulatory guidance for new and existing products. Key Responsibilities : Lead the preparation, submission, and management of FDA 510(k) premarket notifications for medical devices. Prepare and review regulatory documentation to ensure compliance with FDA regulations and standards. Advise product development teams on regulatory requirements and strategy throughout the product lifecycle. Maintain up-to-date knowledge of FDA regulations, guidance documents, and industry best practices. Interface with FDA and other regulatory authorities to respond to inquiries and resolve regulatory issues. Ensure timely submission of regulatory filings, meeting project deadlines and milestones. Support internal audits and inspections related to regulatory compliance. Review labeling and promotional materials to ensure compliance with regulatory requirements. Develop and implement strategies for regulatory approvals in international markets, as needed. Qualifications : Bachelor's degree in Life Sciences, Engineering, or a related field. Minimum of 5-7 years of regulatory affairs experience in the medical device industry. Proven experience in authoring and managing FDA 510(k) submissions. 510(k) number will be requested to verify. Strong understanding of FDA regulations, including 21 CFR Part 820, 21 CFR Part 807, and related guidance. Ability to interpret and apply regulatory requirements to complex technical issues. Excellent communication, organization, and problem-solving skills. Experience in preparing responses to FDA queries and managing interactions with regulatory authorities. Ability to work independently and collaboratively in a cross-functional team environment. Preferred : RAC (Regulatory Affairs Certification) or similar professional certification. Experience with international regulatory submissions (e.g., CE marking, Health Canada). Show more Show less
We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team. Key Responsibilities Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada. Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews. Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content. Conduct regulatory impact assessments for design changes. Qualifications Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field. Minimum of 3 years of regulatory experience in medical device industry. Proven experience contributing to regulatory filings. Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada. Ability to interpret and apply regulatory requirements to complex technical issues. Excellent communication, organization, and problem-solving skills. Experience in supporting responses to regulatory agencies. Ability to work independently and collaboratively in a cross-functional team environment. Preferences Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements. Proven experience in contributing to international regulatory submissions. RAC (Regulatory Affairs Certification) or simliar professional certification Internal Auditor Training Show more Show less
Job Overview We are looking for a highly skilled SAP Business One Developer with expertise in SQL data ingestion to join our team. You will be responsible for designing, developing, and maintaining custom solutions within the SAP Business One ecosystem, with a strong emphasis on ingesting SAP Business One data into the data environment using the data vault modelling method. You will work closely with cross-functional teams to understand business requirements and deliver efficient and scalable SAP Business One solutions, integrations and data ingestion pipelines. Key Responsibilities Custom Development Design, develop, and customize SAP Business One solutions to meet specific business requirements. Create and modify SAP Business One forms, reports, queries, and dashboards. Develop and enhance business logic through the use of SAP Business One SDK (Software Development Kit). SQL Ingestion Strong knowledge and skill set of SQL ETL process using MS SQL Server and database technologies. Knowledge of Data Vault modelling will be highly advantageous. Data Migration Plan and execute data migration activities when implementing SAP Business One or upgrading versions. Ensure data accuracy and consistency during migration processes. Documentation Create and maintain comprehensive documentation of customizations, integrations, and development processes. Provide clear and detailed technical documentation for solutions developed. Technical Support Provide technical support to end-users and assist with troubleshooting and issue resolution. Collaborate with SAP support teams when necessary to resolve complex technical issues. Testing, Quality Assurance & Training Conduct thorough testing of customizations and integrations to ensure they meet business requirements and function as intended. Perform regression testing after SAP Business One upgrades or updates. Train the team in developing & supporting solution developed in Integration Framework Continuous Improvement Stay up-to-date with SAP Business One advancements and best practices. Identify opportunities for process improvement and optimization. Qualifications Bachelor's degree in Computer Science, Information Technology, or a related field (or equivalent work experience). Proven experience as an SAP Business One Developer, with a strong focus on integration. Strong knowledge in SAP Business One Integration framework a must. Proficiency in SAP Business One SDK and integration framework. Experience with SAP Business One is a must. Knowledge of SAP Business One add-ons and extensions. Strong problem-solving skills and attention to detail. Excellent communication and teamwork skills. Ability to work independently and manage multiple tasks simultaneously. Preferred Skills SAP Business One certification is highly desirable. Strong SQL knowledge and skill set is a must. Experience With Other SAP Solutions Or Modules. Familiarity with web services and RESTful APIs. Programming skills in languages such as R, Java, JSON, C#, VB.NET, or SQL. Experience with middleware and ETL tools.
We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team. Key Responsibilities Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada. Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews. Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content. Conduct regulatory impact assessments for design changes. Qualifications Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field. Minimum of 3 years of regulatory experience in medical device industry. Proven experience contributing to regulatory filings. Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada. Ability to interpret and apply regulatory requirements to complex technical issues. Excellent communication, organization, and problem-solving skills. Experience in supporting responses to regulatory agencies. Ability to work independently and collaboratively in a cross-functional team environment. Preferences Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements. Proven experience in contributing to international regulatory submissions. RAC (Regulatory Affairs Certification) or simliar professional certification Internal Auditor Training
We are seeking a highly skilled and motivated eCommerce Specialist to join our team. This individual contributor role is crucial for supporting and managing our portfolio of websites and B2B and B2C stores on Shopify. The ideal candidate will have a strong background in Web Development and Digital Marketing, with experience in Shopify Plus and WordPress CMS. You will work closely with Product Managers, Marketing, and Customer Service teams to ensure seamless operations and exceptional customer experiences. Responsibilities · Bachelor's degree in business, marketing, or related field. · 3+ years of experience in frontend/backend web development, eCommerce and digital marketing. · Hands-on skills in HTML, CSS, JavaScript, Shopify Liquid, PHP, SQL, JSON and REST API. · Proven experience managing B2B/D2C stores on Shopify Plus. · Strong understanding of eCommerce operations including security, compliance, data/privacy laws, best practices, 3PL, inventory and shipping. · Experience with Google Analytics, Event tracking, Pixels, web vitals, performance reporting and supporting ongoing digital marketing campaigns. · Excellent communication and collaboration skills. · Ability to multitask and manage multiple projects simultaneously. · Detail-oriented with strong analytical and problem-solving abilities. · Proactive and self-motivated with a passion for eCommerce.
The IT Helpdesk Analyst – L1 Support acts as the initial point of contact for all internal IT support issues across SOLM. This role focuses on providing frontline support to a global user base across multiple time zones and technologies, with a special emphasis on macOS, Windows, and SaaS tools. The analyst will log and manage tickets via Salesforce Service Cloud , provide timely responses, and deliver an excellent end-user experience. The role requires outstanding communication skills , a calm and soft-spoken demeanor , and the ability to liaise effectively with regional stakeholders and internal teams in a professional, culturally sensitive manner. End-User Support Serve as the first point of contact for all IT-related queries, incidents, and requests via Salesforce Service Cloud (ticketing system). Support end-users across macOS and Windows 10/11 environments. Provide remote assistance using Zoom, Teams, and other collaboration tools. Assist with access issues, password resets, MFA support, and basic software troubleshooting. Issue Troubleshooting & Escalation Troubleshoot hardware and software issues related to: Office 365 (Outlook, Teams, OneDrive) VPN, RDP, internet/network connectivity Printing, conference room equipment, endpoint configurations Escalate unresolved technical issues to L2/L3 support based on standard SLAs. Record all actions, communications, and outcomes in the ticketing system. Stakeholder Engagement & Communication Communicate technical solutions clearly to users with varying technical skill levels. Maintain professionalism when working with international colleagues and leadership. Exhibit excellent verbal and written English communication with a courteous and empathetic approach. Collaborate with internal teams and support global operations across North America, EMEA, LATAM, and APAC regions. Device and Access Management Assist with user onboarding/offboarding (Active Directory, Azure AD, O365). Perform basic macOS user configuration and application setup. Coordinate device provisioning, handoffs, and return logistics. Track assets in alignment with company inventory procedures. Security and Compliance Guide users on secure password practices and endpoint protection basics. Detect and report unusual behavior or phishing incidents to the security team. Ensure compliance with IT security policies in daily support tasks. Evaluate and recommend new technologies and solutions to improve operations. Drive innovation and continuous improvement within the IT infrastructure. Plan and execute technology upgrades and modernization efforts. Implement backup solutions and ensure data integrity and availability. Vendor Management and Collaboration : Manage relationships with vendors and service providers. Evaluate and select third-party solutions and services. Coordinate with external partners for support and services. Ensure vendor deliverables meet organizational standards and requirements. Communication Skills : Effective Communication : Clearly articulate technical concepts and solutions to both technical and non-technical stakeholders. Soft-spoken demeanor , and the ability to liaise effectively with regional stakeholders and internal teams in a professional, culturally sensitive manner. Essential Bachelor's Degree in Computer Science, Information Technology, or equivalent. 3-5 years in an IT Helpdesk or Desktop Support role. Soft-spoken and user-friendly demeanor – with an empathetic approach. Multi-regional collaboration – ability to support and engage across global teams. Problem-solving mindset – proactive, patient, and calm under pressure. Flexible to work on different time zone. Technical qualifications Exposure to ticketing systems like Salesforce Service Cloud , Jira, or ServiceNow. Technical Skills Operating Systems: Windows 10/11, Windows Servers, macOS (basic to intermediate level) ITSM Tools: Salesforce Service Cloud (must), Jira, Remedy Collaboration Tools: Microsoft 365, Teams, OneDrive, Zoom, Slack User Access: Active Directory, Azure AD, MFA tools Endpoint Security: Awareness of antivirus, phishing alerts, and endpoint monitoring basics
We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team. Key Responsibilities Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada. Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews. Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content. Conduct regulatory impact assessments for design changes. Qualifications Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field. Minimum of 3 years of regulatory experience in medical device industry. Proven experience contributing to regulatory filings. Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada. Ability to interpret and apply regulatory requirements to complex technical issues. Excellent communication, organization, and problem-solving skills. Experience in supporting responses to regulatory agencies. Ability to work independently and collaboratively in a cross-functional team environment. Preferences Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements. Proven experience in contributing to international regulatory submissions. RAC (Regulatory Affairs Certification) or simliar professional certification Internal Auditor Training
Job Description : We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will involve working closely with cross-functional teams to ensure compliance with regulatory standards, preparing regulatory submissions, and providing strategic regulatory guidance for new and existing products. Key Responsibilities : Lead the preparation, submission, and management of FDA 510(k) premarket notifications for medical devices. Prepare and review regulatory documentation to ensure compliance with FDA regulations and standards. Advise product development teams on regulatory requirements and strategy throughout the product lifecycle. Maintain up-to-date knowledge of FDA regulations, guidance documents, and industry best practices. Interface with FDA and other regulatory authorities to respond to inquiries and resolve regulatory issues. Ensure timely submission of regulatory filings, meeting project deadlines and milestones. Support internal audits and inspections related to regulatory compliance. Review labeling and promotional materials to ensure compliance with regulatory requirements. Develop and implement strategies for regulatory approvals in international markets, as needed. Qualifications : Bachelor's degree in Life Sciences, Engineering, or a related field. Minimum of 5-7 years of regulatory affairs experience in the medical device industry. Proven experience in authoring and managing FDA 510(k) submissions. 510(k) number will be requested to verify. Strong understanding of FDA regulations, including 21 CFR Part 820, 21 CFR Part 807, and related guidance. Ability to interpret and apply regulatory requirements to complex technical issues. Excellent communication, organization, and problem-solving skills. Experience in preparing responses to FDA queries and managing interactions with regulatory authorities. Ability to work independently and collaboratively in a cross-functional team environment. Preferred : RAC (Regulatory Affairs Certification) or similar professional certification. Experience with international regulatory submissions (e.g., CE marking, Health Canada).