- Aptyx (Charlotte, NC)
- …catheters. This role is intended for candidates at the Engineer II through Senior Engineer level who are comfortable working hands on, driving technical ... in collaboration with operations, tooling, and quality teams. Prepare documentation including design history file elements, risk management documents, protocols,… more
- Oracle (Raleigh, NC)
- …AI-enabled population health platform. To support these efforts, we are hiring ** Regulatory Technical Documentation Engineers** with **deep engineering ... documentation + Experience preparing documentation for audits, technical files, or regulatory submissions. **Preferred** + Experience in healthcare,… more
- TD Bank (Charlotte, NC)
- …developing and maintaining TD's US Recovery and Resolution Plans and other regulatory submissions, as required under the Dodd-Frank Act and other applicable ... regulations. This role will act as a industry liaison for regulatory policy, including engagement with trade associations; will be responsible for monitoring … more
- Teleflex (Morrisville, NC)
- Senior Regulatory Affairs Specialist **Date:** Dec 2, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation , and...and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.… more
- The Clorox Company (Durham, NC)
- …**Your role at Clorox:** The Senior Regulatory Specialist will ... Cosmetics Direct). ** Documentation & Communication** + Prepare and review regulatory documentation including but not limited to ingredient assessments,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …post-approval supplements). Determine regulatory CMC content and scientific/ technical requirements to ensure documentation meets regulatory ... Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process...Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop… more
- Oracle (Raleigh, NC)
- …leadership, presenting data-driven recommendations and guiding cross-functional alignment. + ** Technical Documentation :** Help lead the efforts across both ... and compliance activities** as HDI expands globally. Ensure operational processes and documentation align with regulatory standards and help drive readiness for… more
- GRAIL (Durham, NC)
- …initiatives to enhance efficiency, reliability, and quality. + Prepare comprehensive technical documentation , scientific reports, and regulatory submission ... audits (internal, regulatory , or client-driven). + Excellent skills in technical documentation and scientific writing. + Demonstrated ability to collaborate… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …world of health in ways you may never have imagined in your career. The Senior Technical Manager is responsible for ensuring the latest security requirements and ... Participate in delivery of all required product security quality and regulatory documentation associated with product launches. + **Operational Management:**… more
- Oracle (Raleigh, NC)
- …and ability to summarize complex trade-offs and options in presentation and technical documentation . + Ability to effectively represent engineering perspectives ... and working on ambitious new initiatives. A TPM at any level can have significant technical and business impact here. You will be part of a team of hard-working,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …regulatory liaison in collaborative projects with other companies + Ensures that technical documentation for regulatory submissions meets the appropriate ... cross functional teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and… more
- Truist (Charlotte, NC)
- …advice to the Director of Financial Reporting, Deputy Corporate Controller and other senior leaders on regulatory reporting matters. * Lead the development of ... advice to the Director of Financial Reporting, Deputy Corporate Controller and other senior leaders on regulatory reporting matters. * Lead the development of… more
- Teleflex (Morrisville, NC)
- …peers to establish key risks and develop program implementation plans. * Manage Technical Documentation . * Manage Global regulatory impact assessments. * ... total cost of goods sold. The role of the Senior Regulatory Affairs Specialist is focused on...and Risk Management (ISO 14971) experience required * Excellent technical writing experience within a medical device environment -… more
- GRAIL (Durham, NC)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor… more
- Lilly (Durham, NC)
- …for US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory , Global Patient Safety, Qualified Persons at ... OUS regulatory agencies Generate, submit and maintain product shortage documentation following local procedure. + Provide information for use in various periodic… more
- Oracle (Raleigh, NC)
- …of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends ... and deficiencies. + Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and… more
- SMBC (Charlotte, NC)
- …within the Risk Technology Group. This role is pivotal in overseeing regulatory stress testing platforms, ensuring compliance with Federal Reserve requirements, and ... innovation across risk systems. The ideal candidate will possess deep technical expertise, strong leadership capabilities, and the ability to collaborate across… more
- Oracle (Raleigh, NC)
- …Key Responsibilities 1. Strategic Technical Leadership + Serve as the senior technical authority on designing and delivering AI/ML-powered health data ... scale. + Influence product roadmaps by representing real-world customer requirements, regulatory constraints, and innovation opportunities to senior product and… more
- TD Bank (Charlotte, NC)
- …and implement a forward-thinking compliance program for the future. Beyond technical expertise, we're looking for someone with an entrepreneurial mindset-someone who ... standards. **Department Overview:** **U.S. Wealth Compliance acts as an independent regulatory compliance and conduct risk management and oversight function as… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Senior Manager - Quality Assurance, Data Integrity Officer Department: Quality Plant Head Location: Monroe, NC START YOUR APPLICATION ... (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3591083&source=3591083-CJB-0) POSITION SUMMARY: The Senior Manager - Data Integrity Officer (-DIO-) is responsible… more
