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Toxicologist
Location
United States
Posted
10 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Toxicologist
NAMSA
Role Description - Participate in meetings with prospective clients. - Provide scope of project and relevant information to support the creation of proposals. - Offer opportunities to clients for expansion of MRO services to be provided by NAMSA. - Prepares risk assessments, evaluation plans and reports, in compliance with ISO 10993-1, ISO 10993-17, and ISO 14971, for submissions to FDA and other regulatory agencies. - Evaluates and summarizes biocompatibility and general toxicology data ensuring compliance with the relevant regulatory requirements and standards. - Working knowledge of FDA and EU MDD and other global medical device regulations and/or biologics regulations, ISO 10993 series, and 14971. - Ensure biocompatibility studies are in compliance with most recent regulatory requirements. - Performs and summarizes Clinical Evaluations. - Provide technical support to lab staff. - Advise clients on technical issues related to biocompatibility and material characterization. - Develop proposals for Biological Safety projects. - Perform biocompatibility gap analysis and write clear concise report. - Performs and summarizes literature searches. - Facilitate the collection of test data from other NAMSA entities as they relate to a specific project. - Evaluates and determines biological relevance of unexpected results. Qualifications - Bachelor’s degree or equivalent experience in a related field, and a minimum of 5 years of relevant experience; or - Master’s or Doctorate degree or equivalent experience in a related field, and a minimum of 2 years of relevant experience. - DABT Certification Required - Knowledge of and experience with Microsoft Word - Write and review complex documents Requirements - The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - While performing the duties of this job, the employee is regularly required to talk or hear. - The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. - The employee must occasionally lift and/or move up to 25 pounds. - Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. - Extensive use of a computer keyboard. Benefits - NAMSA is an equal employment opportunity company. - NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
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Role Description As an Operations Manager, Contracts & Compliance, you will oversee critical functions that support the business, including: - Contract administration - Compliance coordination - Legal operations support - Business licensing - Process documentation - Operational project management You will work closely with leaders across the organization to ensure: - Agreements are executed accurately - Compliance requirements are met - Risks are proactively managed - Operational processes are scalable and effective This role offers an opportunity to make a meaningful impact by: - Creating structure - Driving consistency - Improving how work gets done across multiple teams Your efforts will help ensure Cohere remains well-positioned to deliver exceptional service while continuing to grow with purpose. Qualifications - 3-5+ years of experience in operations, contract administration, compliance, legal support, project coordination, or a related field - Strong organizational skills and exceptional attention to detail - Excellent written and verbal communication skills - Ability to manage multiple priorities and deadlines in a fast-paced environment - Strong analytical and problem-solving abilities - High level of integrity, professionalism, and discretion - Proficiency with Microsoft Office and document management systems - Experience working with contracts, legal documentation, or compliance programs - Familiarity with business licensing, insurance administration, or regulatory compliance - Experience using workflow and document management platforms such as Monday.com, SharePoint, or similar systems - Ability to work independently and collaboratively across teams Requirements - Bachelor's degree in Business Administration, Operations, Legal Studies, or a related field preferred - Experience in community management, real estate, homeowner associations, or related industries preferred - Ability to occasionally travel for meetings, training, or company events, as needed Benefits - Medical coverage available on your first day - Employer-paid dental coverage - Vision coverage - 401(k) retirement plan - Employer-paid Life Insurance, AD&D, and Long-Term Disability coverage - Pet insurance options - Employee Assistance Program with mental health, financial, legal, and family support resources - Travel assistance and identity theft protection - Complimentary will preparation services - Generous paid time off - 16 paid holidays each year, including a Birthday Day and Volunteer Day, in addition to PTO - Professional development and growth opportunities
• Support payer audits and medical record reviews, ensuring timely and accurate submission of requested documentation • Manage medical review requests and appeals associated with CMS contractors, regulatory agencies, and billing intermediaries • Review clinical documentation using established audit and submission checklists • Partner with operational and clinical teams to gather and validate required records • Participate in chart reviews and compliance monitoring initiatives across the organization • Assist with risk identification activities and regulatory readiness efforts • Support investigations and corrective actions related to compliance findings • Maintain audit tracking and outcomes through documentation systems and reporting tools • Navigate multiple EMRs, payer portals, and operational systems to manage submissions and appeals • Contribute to training and educational materials that strengthen compliance knowledge across teams • Participate in internal quality, billing, and operational review activities • Complete additional regulatory and administrative projects as assigned
• Maintain product compliance documentation for all ThermalWorks products manufactured for the North American and European markets, ensuring that documentation reflects current product configurations and applicable regulatory requirements. • Coordinate third-party certification activities with applicable certification authorities and notified bodies, including submission preparation, field labeling remediation, and authorization correspondence. • Support product safety and conformity assessment processes across multiple jurisdictions, including the preparation of declarations of conformity and related regulatory documentation. • Track pressure equipment, environmental substance, and hazardous-area compliance for product lines and components as applicable to destination markets. • Support the preparation and submission of regulatory ratings documentation, including electrical, mechanical, and safety ratings required for product listing and labeling. • Serve as the compliance interface within ThermalWorks' Engineering Change Request (ECR) and Engineering Change Notice (ECN) workflow, ensuring that every change with regulatory implications is reviewed, documented, and routed to the appropriate certification authority where required. • Track variation notices and related compliance documentation required for changes to certified product configurations, including component substitutions, supplier changes, and design revisions. • Review Bills of Materials (BOMs) and engineering drawings to identify components requiring compliance review prior to release. • Coordinate with Engineering and Quality teams to ensure that technical specifications, cut sheets, and regulatory ratings are attached to engineering changes at submission rather than retrieved retroactively. • Support the resolution of compliance documentation gaps, including instances where a component appears in production use but is not reflected in the current certification documentation. • Maintain compliance documentation within the company's product lifecycle management, asset management, and document management systems, ensuring version control, retention policy compliance, and accessibility for internal audits and regulatory inquiries. • Support the transition of compliance records into the company's evolving enterprise systems landscape, including integration between product lifecycle management, service management, and enterprise resource planning platforms. • Prepare and maintain product nameplate and labeling documentation, ensuring that all units shipped to customers carry accurate, current, and regulator-compliant identification. • Support asset tracking and traceability integration, ensuring that asset-level data flows correctly into the company's quality and compliance management systems. • Maintain the manufacturing bulletin library and ensure that withdrawn, superseded, or revised bulletins are appropriately archived and communicated to manufacturing partners. • Serve as a documentation point of contact for certification authorities and notified bodies, supporting the Compliance Officer in scheduling inspections, providing technical packages, and routing authorization letters. • Coordinate compliance information flow with contract manufacturers in multiple regions, ensuring alignment on product configurations, change implementation, and documentation. • Support manufacturing site quality and compliance reviews, including periodic self-audit processes and third-party assessments conducted by certification authorities. • Track and document compliance-related communications with key component suppliers, particularly where supplier-side changes (capacity constraints, component substitutions, or supply-driven events) carry compliance implications. • Travel up to 20% of the time to support compliance activities at ThermalWorks sites, manufacturing partner sites, customer commissioning events, and certification authority meetings. • Participate in the daily Operations review cadence and contribute to the company's open projects tracker for compliance-owned items. • Support cross-functional initiatives that coordinate lifecycle, quality, and compliance decisions across the engineering, operations, and service functions. • Provide compliance perspective during proposal review, customer technical reviews, and submittal preparation, particularly for projects in jurisdictions where regulatory complexity is highest.
• Shape policy outcomes: Proactively influence state and federal hemp beverage regulations before they're finalized - focusing on packaging standards, DTC frameworks, and market access • Drive advocacy campaigns: Represent Willie's in state-level advocacy, industry coalitions, trade associations, and regulatory working groups • Build strategic relationships: Cultivate relationships with state regulators, policymakers, legislative staff, and key stakeholders • Develop policy positions: Create regulatory comments, white papers, testimony, and advocacy materials that influence outcomes in priority markets • Monitor and analyze: Track legislative and regulatory developments across priority states and advise leadership on strategic response - anticipating shifts, not just reporting them • Maintain industry presence: Actively participate in trade associations, industry events, and coalitions to stay ahead of political and commercial trends • Serve as internal expert on state hemp beverage frameworks across active and expansion markets • Guide market prioritization and entry strategies based on regulatory feasibility and advocacy opportunities • Partner with product, marketing, legal, and sales teams to integrate regulatory insight into go-to-market strategy and commercial decisions • Provide strategic direction to the compliance function to ensure execution aligns with markets you're opening


