Job Description
Description:
Key Responsibilities:
Required Regulatory Knowledge
Documentation Maintenance:
Compensation: The hourly rate for this position is between $24-$26 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
- The Regulatory Affairs representative serves as the designated responsible person for global product registration and regulatory compliance activities. This role leads registration, licensing, submission, and documentation activities while acting as the primary regulatory liaison to internal teams, regional representatives, and regulatory authorities to ensure continued market access throughout the product lifecycle.
Key Responsibilities:
- Product Registration & Approvals: Serve as the designated regulatory representative for product registrations, listings, licenses, notifications, and approvals, ensuring accurate and timely submission to regulatory authorities.
- Regulatory Submissions: Prepare, coordinate, and compile European Union Technical Documentation, Canadian and other International Regulatory packages and supporting documentation to meet regional and global requirements.
- Stakeholder Liaison: Act as the primary regulatory point of contact for internal and external stakeholders, providing guidance on regional registration requirements and communicating the regulatory impact of product changes. Ensure timely communication with stakeholders to meet regulatory requirements
- Cross-Functional Coordination: Coordinate regulatory activities and communications to support submission timelines, project milestones, and alignment with stakeholders.
- Documentation & Records Control: Create, review, update, and maintain regulatory documentation and records within approved document management systems in accordance with document control requirements, ensuring records remain accurate, current, and readily accessible for audits, inspections, and submissions.
- Compliance & Market Access: Support continued commercialization by ensuring regulatory approvals and registrations are maintained in compliance with applicable regulations and quality system requirements.
Required Regulatory Knowledge
- In Vitro Diagnostic Regulation (IVDR): Broad working knowledge of EU IVDR (Regulation (EU) 2017/746) requirements, including classification, conformity assessment, technical documentation, and registration obligations for in vitro diagnostic devices.
- Canadian Regulations: Broad knowledge of Health Canada regulatory requirements, including the Medical Devices Regulations (SOR/98-282), medical device licensing (MDL), establishment licensing (MDEL), and applicable registration and listing requirements.
- Global Regulatory Frameworks: Familiarity with applicable international regulatory requirements to support multi-region registration, licensing, and ongoing compliance activities.
Documentation Maintenance:
- Maintain regulatory records and documentation including submission files, registrations, licenses, approvals, and supporting records ensuring version control, timely revision to reflect product or registration changes, and retention in compliance with applicable document control procedures.
- Ability to maintain confidentiality of information and materials
Compensation: The hourly rate for this position is between $24-$26 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Numbers & Facts
| Location | West Sacramento, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $24–$26 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
Skills
- Analysis Skillsunmatched
- Cross-Functionalunmatched
- Document Controlunmatched
- Document Managementunmatched
- Documentationunmatched
- Geographyunmatched
- Health Canada Requirementsunmatched
- Licensingunmatched
- Licensing Complianceunmatched
- Medical Equipmentunmatched
- People Managementunmatched
- Product Lifecycleunmatched
- Product Marketingunmatched
- Record Keepingunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Regulatory Submissionsunmatched
- Source Code/Configuration Management (SCM)unmatched
- State Laws and Regulationsunmatched
- Technical Writingunmatched
- Time Managementunmatched
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