Regulatory Affairs Jobs

Senior Systems Engineer

null **If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may c** **ontact 888-367-7223, option 5, for assistance.** **In this role, you have the opportunity to** […]

Quality Business Excellence Manager

null **In this role, you have the opportunity to** Play a key role in our Domestic Appliances business, helping to measure and drive our business and quality performance, and supporting improvement initiatives to transform our organization and processes. **You are responsible for** + Supporting the Q&R business excellence team + Leading the critical transformation or […]

Post Market Surveillance & Risk Management Integration Leader

null **If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may c** **ontact 888-367-7223, option 5, for assistance.** **In this role, you have the opportunity to** […]

Director Quality Operations – International Markets

null **In this role you have the opportunity to:** Reporting to the Quality leader International Markets, you will lead the International Market Operational Quality team. You will be a key partner to International Market enabling disciplines (e.g. Regulatory Affairs (RA), Supplier Quality (SQ), Services & Solution Delivery (S&SD), Customer Services), Global Group Function and Business […]

Regulatory Affairs Specialist III (REMOTE)

Job Responsibilities • Conduct post-market changes assessment • Supports design changes and sustainment projects •Actively participate in project core teams and collaboratively achieve project goals and meet timelines •Partner with global and regional marketing in the development of regulatory plans •Formulate short-term planning for individual deliverables and participate in long term planning within the organization […]

Manager, Regulatory Affairs/Quality Affairs Software Applications

This position consists of three primary functions: Managing department projects with strong focus on software applications to support, grow and improve departmental processes. Managing Danaher global software implementation projects. Providing compliance and process improvement support through project management, training, creating standard work, kaizens and workshop facilitation and support for enterprise, platform, OpCo and department support; […]

Senior Specialist, RA

Senior Regulatory Affairs Specialist With a specific focus on US: + Ensuring collaboration with the global regulatory team in preparing global regulatory strategies, identifying regulatory opportunities, and mitigating risks and coordinating regulatory activities in collaboration with relevant team members. + Planning and managing meetings with FDA and Health Canada. + Driving and leading the preparation […]

Principal Regulatory Affairs Specialist (REMOTE)

Essential Job Responsibilities • Interpret federal/state/international regulations as they apply to Cepheid products, processes and/or procedures.• Advise on impact of regulations, devise strategies for compliance, and liaison with regulatory bodies. Investigate and resolves compliance problems, questions and complaints.• Audit and evaluate current policies, procedures, and documentation for compliance with regulations and statutes.• Actively participate in […]

Manager Regulatory Affairs

+ Provide regulatory support for assigned responsibilities as an individual contributor, directly accountable for providing support to regulatory strategists, for example, managing documentation/information requests, authoring / compilation of submission packages and responses to regulatory queries, strategy documents, LAD documents, updating systems in line with regulatory processes and procedures. + Lead assigned clinical study meetings + […]

Supervisor

**ROLE SUMMARY** QA Supervisor – Aseptic will be primarily based at the Sterile Product Manufacturing (SPM) building and will provide general oversight to Quality Inspector colleagues. The ideal candidate will possess a working knowledge of aseptic processing principles including aseptic behaviors, good documentation practices (GDP), good manufacturing practices (GMP), facility controls and compliance / regulatory […]

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