Regulatory Affairs Engineer

Responsibilities:Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reportsExperienced in authoring of assessment reports and Part2/ Expert reports for DossiersExperience in reviewing of quality documents such as Reformulation studies, process validations, particle size method...

Responsibilities: 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 validations, particle size method...

Responsibilities: 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 validations, particle size...

Are you a seasoned Regulatory Affairs professional with a passion for ensuring compliance and driving regulatory strategy in the medical device industry? We're are on the look out for a dynamic Regulatory Affairs Director to lead regulatory initiatives for a one-of-a kind start-up in the Medical Device space. As a key member of the team, you'll play a...

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...

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...

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 into the Manager responsible...

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...

Under minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position Regulatory Affairs, Specialist, Regulatory, Diagnostic, Cardiac, International

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...

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...

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...

Recruiter: Spencer Gregory Hale Regulatory Specialist II, Electrophysiology Pulsed Field Ablation, Regulatory Affairs At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and...

Innovation Center, 777 Forest Edge Dr, Vernon Hills, Illinois, United States of America Req #1712 Friday, May 3, 2024 Job Overview: The Regulatory Manager will be instrumental in helping to ensure the company successfully meets all compliance requirements while achieving critical deadlines for key regulatory demands. This includes the management and...

The Stellantis Technical Safety and Regulatory Certification (TSRC) S tude nt P rogram P articipant will have the opportunity to work in the exciting world of regulatory certification and compliance. This role perform s certification and compliance testing and analysis to support emissions and OBD (Onboard Diagnostics) certi fication for all vehicles sold in...

Job Description The Stellantis Technical Safety and Regulatory Certification (TSRC) Student Program Participant will have the opportunity to work in the exciting world of regulatory certification and compliance. This role performs certification and compliance testing and analysis to support emissions and OBD (Onboard Diagnostics) certification for all...

Job Description: Pay Range $55hr - $75hr Responsibilities: Develop global or regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. Develop strategic direction and provide leadership for all regulatory interactions with...

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...

The Stellantis Technical Safety and Regulatory Certification (TSRC) Student Program Participant will have the opportunity to work in the exciting world of regulatory certification and compliance. This role performs certification and compliance testing and analysis to support emissions and OBD (Onboard Diagnostics) certification for all vehicles sold in the...

The Stellantis Technical Safety and Regulatory Certification (TSRC) Student Program Participant will have the opportunity to work in the exciting world of regulatory certification and compliance. This role performs certification and compliance testing and analysis to support emissions and OBD (Onboard Diagnostics) certification for all vehicles sold in the...