- Cytiva (Miami, FL)
- …and other functions, and facilitate risk-based decisions.Prepare, update and review regulatory support documentation, including Validation Guides, statements, ... about the Danaher Business System which makes everything possible.The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the Business… more
- Beckman Coulter Diagnostics (Miami, FL)
- …that address the world's biggest health challenges. The Senior Staff Global Process Owner (GPO) Quality Assurance for Beckman Coulter Diagnostics is responsible to ... and integration of the Corrective and Preventive Action (CAPA) process into our global Quality Management System (QMS) in...the role of CAPA Manager of the Global CAPA Review Board (CRB). This position is part of the… more
- Aldevron (Miami, FL)
- …Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic ... as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality AgreementsDevelop and… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …protocols, reports and SOPs in support of the stability program, including review and implementation of regulatory requirements for the stability ... off-site laboratory facilities (as needed).Ensure data is evaluated, including the creation, review and trending of data, to meet customer, industry and … more
- Aldevron (New York, NY)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... with regulatory requirements and company branding.This is a remote position...control mechanisms, such as document control, change management, and review cycles, to maintain labeling integrity.Collaborate with internal stakeholders:… more
- Cytiva (Miami, FL)
- …as related to compliance with internal and external quality and regulatory standards. Assist with the implementation of standard operating procedures to ... to establish and maintain document controls that align with applicable regulatory requirements. Ensure compliance with documentation requirements defined in ISO… more
- Pall (Miami, FL)
- …inspection and test, performance monitoring and supplier development. May manage process and product non-conformances in line with company procedures. May conduct ... quality assurance tests to ensure product specifications are met. May review , investigate, resolve, and report on quality discrepancies. May develop, maintain,… more
- Cepheid (Miami, FL)
- …maintained in a high state of compliance.Ensure Clinical Affairs compliance with review process for manuscripts and other scientific communications generated by ... the Clinical Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals.Evaluation, acquisition, and… more
- American Express (New York, NY)
- …Qualification:** + Master's degree in Finance/Accounting. CPA is a plus. + Knowledge of regulatory audit or process review is a plus. **Qualifications** ... team is responsible for ensuring governance and oversight of regulatory reporting process . The team performs Quality...to:** + Lead Quality Assurance reviews which include: + Process review to identify control gaps and… more
- American Express (Salt Lake City, UT)
- …Banking/Financial Services. * Knowledge of financial and regulatory reporting. * Knowledge of regulatory audit or process review is a plus. * Proven ... * Leading multiple Quality Assurance reviews which include: + Process review to identify control gaps and...and audits eg, Federal Reserve Exam, Internal Audit Group review and others. * Support regulatory reporting… more
- Genesis Healthcare (WV)
- …Advisor is responsible for overseeing Regulatory compliance and the Quality Review process that supports compliance to state and federal regulations, as ... Review . 6. Will ensure the approved Quality Review process will be followed accordingly and...and present training sessions for Market related to survey process , regulatory guidelines and any other related… more
- Abbott (Abbott Park, IL)
- …Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. + Post market: Maintain annual ... Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review . Monitor and submit applicable reports to … more
- Takeda Pharmaceuticals (Boston, MA)
- …Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). Provide regulatory guidance during development, ... for prescription medicines. + Experience in prescription medicine promotion development and review process . + Strong interpersonal skills with ability to… more
- Abbott (Lake Forest, IL)
- …stakeholders. + Negotiate with regulatory authorities during the development and review process to ensure submission approval. + Provide strategic input and ... guidelines of the regulatory profession, clinical research, and regulatory process . Apply Now (https://www.jobs.abbott/us/en) * Participants who complete… more
- Abbott (Santa Clara, CA)
- …Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. **Postmarket:** + Maintain annual ... Monitor impact of changing regulations on submission strategies. + Monitor applications under regulatory review . + Monitor and submit applicable reports to … more
- Abbott (Sylmar, CA)
- …+ Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval + Provide strategic input and ... submission strategies and update internal stakeholders + Monitor applications under regulatory review + Communicate application progress to internal stakeholders… more
- Sanofi Group (Cambridge, MA)
- …mile" and work with agility + Experience with MLR (Medical, Legal, Regulatory ) review process + Excellent organizational, interpersonal, communication, ... as well as navigating internal ways of working such as Medical/Legal/ Regulatory review . Collaborative, solution-orientated, self-starter and outcomes-driven are… more
- Abbott (Plymouth, MN)
- …Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. + Manage and execute preapproval ... submission strategies and update internal stakeholders. Monitor applications under regulatory review . Communicate application progress to internal stakeholders.… more
- Edwards Lifesciences (Irvine, CA)
- …project(s), propose suggestions on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, ... inclusion in regulatory submissions. + May interact with regulatory agencies as part of submission review and on-site audit support (eg, US FDA, EU notified… more
- Edwards Lifesciences (Irvine, CA)
- …project(s), propose suggestions on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, ... inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review ...with regulatory agencies as part of submission review and on-site audit support. (eg, IDE's, PMA's, annual… more
