Regulatory Affairs Specialist

Support and prepare documentation for regulatory submissions and registrations (FDA and EU regulatory entities) IDE, PMA, 510 (k), Design Dossiers, Technical Files. Maintain regulatory Technical Files Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements...

Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle. This role is...

The Senior Director of Regulatory Affairs will be responsible for the full range of regulatory matters related to our products and compliance with industry regulations, both internal and external,including:general regulatory monitoring and compliance, regulatory analysis of new productdevelopment opportunities, issue-specific advocacy on our own behalf and...

Principal Regulatory Affairs About the role: At Boston Scientific, you'll discover a place where you can find meaningful purpose, improving lives through your life's work. The Global Regulatory Affairs Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment. This individual will report...

  Principal Regulatory Affairs   About the role: At Boston Scientific, you’ll discover a place where you can find meaningful purpose, improving lives through your life's work. The Global Regulatory Affairs Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment. This...

Job DescriptionJob DescriptionPosition: Data Analyst-Marketing Location: Short Hills, NJDuration: 1 YearJob Description:We are seeking a highly skilled and experienced Data Analyst specializing in Marketing to join our team. The ideal candidate will have a strong background in regulatory affairs, particularly in the pharmaceutical, vaccine, or biological...

Job DescriptionJob DescriptionJob Description: We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States Manage execution / authoring and review of CMC documentation (Module 1 , 2...

Job DescriptionJob DescriptionJob Description: Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in reviewing of quality documents such as Reformulation studies, process...

The Regulations and Government Relations Engineer is responsible for conducting vehicle and engine testing, data collection, processing, and analysis. In addition this person would also be responsible for writing reports and preparing technical presentations for both internal management and external customers.Qualifications:In-depth knowledge of working...

The Regulations and Government Relations Engineer is responsible for conducting vehicle and engine testing, data collection, processing, and analysis. In addition this person would also be responsible for writing reports and preparing technical presentations for both internal management and external customers.Qualifications:In-depth knowledge of working...

Job descriptionWe are a rapidly growing insurance administrator in search of a subject matter expert in compliance, administration, process, and procedure. We are looking for a team player who thrives in in a fast-paced environment and is comfortable with managing competing compliance projects and deliverables on tight timelines. If you are passionate about...

Job DescriptionJob DescriptionPosition Summary:Senior Wellness Specialists are responsible for providing patients with a dedicated point of contact to receive high quality and personalized service pertaining to the healthcare products available through Transcend. The Senior Wellness Specialist role shares qualities between that of; a Consultative Sales...

Job DescriptionJob DescriptionWe are seeking a HR/ Administrative Specialist in Farmington Hills, MIClient: Japanese Automotive (Tier 2)General Position SummaryThe HR /Administrative Specialist is responsible for supporting various HR and General Affairs administrative activities and will run the daily functions of the HR department including hiring,...

Job DescriptionJob DescriptionPosition Summary:Wellness Specialist I are responsible for providing patients a dedicated point of contact to receive high quality and personalized service pertaining to the healthcare products available through Transend. The Wellness Specialist role shares qualities between that of; a Consultative Sales Rep/Account Manager, and...

Corporate Compliance Risk Assessment SpecialistThe Corporate Compliance Risk Assessment Specialist reports to the Manager of Corporate Compliance Risk Assessment and is responsible for supporting the day-to-day execution of the Corporate Compliance Risk Assessment (CCRA) Program. This includes managing templates and data inputs, supporting the execution of...

Quality Assurance Specialist (QA) – is responsible for the review and approval of objective evidence of quality of examination, inspection, and test results for conformance/compliance to Code, Energy Steel requirements, and customer purchase order requirements. The QA Specialist compiles the Energy Steel certification documents and releases material for...

Quality Assurance Specialist (QA) – is responsible for the review and approval of objective evidence of quality of examination, inspection, and test results for conformance/compliance to Code, Energy Steel requirements, and customer purchase order requirements. The QA Specialist compiles the Energy Steel certification documents and releases material for...

Job Number: 66158 Group: Magna Electronics Division: Magna Electronics Auburn Hills Job Type: Permanent/Regular Location: AUBURN HILLS Work Style: About usWe see a future where everyone can live and move without limitations. That's why we are developing technologies, systems and concepts that make vehicles safer and cleaner, while serving our communities,...

ACELYRIN INC, CA, USA ACELYRIN INC **Medical Director, Clinical Development** At ACELYRIN, INC the patient is at the center of our culture and our business. We are guided by our values of courage, compassion, collaboration, innovation, and a sense of urgency. Our key value of courageous caring means putting patients first and having the courage needed to...

Job DescriptionJob DescriptionJob Overview:We are seeking a dedicated and meticulous Customer Experience Specialist to join our Client's team. This role is pivotal in managing internal account functions, supporting our remote Account Managers, and ensuring the smooth operation of sales order processes. The position requires strong attention to detail,...