Regulatory Affairs Associate/IVDR

Project Manager - IVDR - Performance Evaluation Coordinator This candidate needs to have strong Medical Device exp (no Pharma/Bio) and has a good medical writing/technical writing background. They will be evaluating documentation and needs to be strong with performance evaluations, document creation and have a demonstrated PM background to manage this...

Project Manager - IVDR - Performance Evaluation CoordinatorThis candidate needs to have strong Medical Device exp (no Pharma/Bio) and has a good medical writing/technical writing background.They will be evaluating documentation and needs to be strong with performance evaluations, document creation and have a demonstrated PM background to manage this...

Project Manager - IVDR - Performance Evaluation CoordinatorThis candidate needs to have strong Medical Device exp (no Pharma/Bio) and has a good medical writing/technical writing background.They will be evaluating documentation and needs to be strong with performance evaluations, document creation and have a demonstrated PM background to manage this...

Project Manager - IVDR - Performance Evaluation CoordinatorThis candidate needs to have strong Medical Device exp (no Pharma/Bio) and has a good medical writing/technical writing background.They will be evaluating documentation and needs to be strong with performance evaluations, document creation and have a demonstrated PM background to manage this...

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...

Accountability / Scope:As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions...

As a Director Wellbeing & Regulatory Affairs (Salty, Portable Wholesome Snacks & Customer Activation), you will drive differentiation and enable share growth. This will be achieved by providing strategic wellbeing & regulatory thought leadership to K Regulatory Affairs, Director, Regulatory, Communications, Manufacturing, Business Services, Business

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements. Main Responsibilities Lead the US & Canada Regulatory team to...

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements.Main ResponsibilitiesLead the US & Canada Regulatory team to...

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements.Main ResponsibilitiesLead the US & Canada Regulatory team to...

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements.Main ResponsibilitiesLead the US & Canada Regulatory team to...

Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existing and new product submissions to the FDA and Canada. Leading a small team, this is for somebody with prior Regulatory management experience and knowledge of IVD requirements. While professional experience and qualifications are key for...

**Company Description** The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Supports regulatory objectives for the management of IVD/CDx global...

Job Title: Regulatory SpecialistDuration: 6 months (Potential extension)Location: Hybrid - Chicago, IL 60642SummaryAs a member of the Scientific & Regulatory Affairs (SRA) team, this role focuses on screening, tracking, and managing regulatory information related to ingredients. Ensuring the accuracy and completeness of ingredient data is crucial for...

Job Title: Regulatory Specialist Duration: 6 months (Potential extension) Location: Hybrid - Chicago, IL 60642 Summary As a member of the Scientific & Regulatory Affairs (SRA) team, this role focuses on screening, tracking, and managing regulatory information related to ingredients. Ensuring the accuracy and completeness of ingredient data is crucial for...

Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

Communicates with the CCTO study teams and disease programs distributing new NCTN study activations, closures, termination, amendments and safety reports, etc. - Processes IRB, submissions to include but not limited to annual reviews and Adverse Even Regulatory, Coordinator, Clinical, Audit, Regulatory Affairs, Project Management, Business Services

OVERVIEWIf you have a background in chemical regulatory compliance and want to work for a company that has been at the forefront of innovation for over 60 years, consider applying for this REMOTE position with occasional on-site meetings in Aiken/Augusta area. QUALIFICATIONS2-3 years recent and/or current background in Chemical Regulatory Compliance ANDSDS...

OVERVIEWIf you have a background in chemical regulatory compliance and want to work for a company that has been at the forefront of innovation for over 60 years, consider applying for this REMOTE position with occasional on-site meetings in Aiken/Augusta area. QUALIFICATIONS2-3 years recent and/or current background in Chemical Regulatory Compliance ANDSDS...

Job Description: Medical Director, Medical Affairs Overview: Join our client's team as a Medical Director, Medical Affairs, where you will provide medical, scientific, strategic, and operational leadership. You will play a key role in activities such as generating clinical and scientific data, enhancing therapeutic benefit, ensuring safety and value,...