- 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
- 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
- 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
- Parexel (Raleigh, NC)
- …regulations. + Broad experience in preparation of all types of clinical regulatory documentation . Experience in management of complex medical writing projects. ... The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales… more
- Parexel (Raleigh, NC)
- **Job Summary:** The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as ... to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator… more
- Parexel (Raleigh, NC)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... reports required information to resolution + Submit all required reports, documentation , updates and tracking within required timeframes, including but not limited… more
- GRAIL (Durham, NC)
- …companies. For more information, please visit grail.com . Reporting to the Senior Director, Quality Strategy & Operational Excellence, the Senior Quality ... these programs in compliance with GRAIL's Quality Management System procedures and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR,… more
- The Clorox Company (Durham, NC)
- …as texture, scent, appearance, and usage behavior. Develop and maintain documentation and design standards related to consumer experience, including sensory targets, ... aesthetic criteria, and technical briefs. Lead product prototyping, benchmarking, and experiential testing to guide decision-making throughout the development… more
- Teleflex (Morrisville, NC)
- Senior Engineer, Software Development **Date:** Nov 29, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... we are committed to empowering the future of healthcare. As a Senior Engineer specializing in Software, you will be instrumental in implementing technological… more
- Banc of California (Durham, NC)
- …and make recommendations. Maintain knowledge and awareness of financial industry technical status, trends, and regulatory requirements. + Additional ... of employee resource groups, and more. TOGETHER WE WIN(R) **THE OPPORTUNITY** The VP, Senior Business Continuity Planning Officer role is a key role that is second… more
- Applied Research Associates, Inc. (Raleigh, NC)
- …teams, make independent decisions, and advise leadership under complex operational and regulatory conditions. + Strong technical understanding of access control ... Security Operations Manager serves as a decisive leader who applies strong technical expertise and sound judgment to guide leadership decisions, mitigate risk, and… 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
- 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
- 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
- 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
- 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
