Regulatory Writer Specialist

Regulatory Writer OpportunityWe are seeking an experienced regulatory writer to join our team.The ideal candidate will have a strong background in scientific/technical writing and editing, as well as experience with complex standard operating procedures (SOPs), guidance documents, and work instructions.Responsibilities include authoring and gaining approval...

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at...

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at...

Global Regulatory Writing DirectorThis is a leadership position that requires strong expertise in regulatory writing, scientific data analysis, and project management.Responsibilities:Oversee the review and approval of regulatory submission documents.Lead functional area teams and maintain key relationships with cross-functional team members.Provide guidance...

Job Title: Regulatory Compliance SpecialistThe role of a Regulatory Compliance Specialist is to ensure that our organization's products and services comply with all relevant laws, regulations, and industry standards. This includes maintaining accurate documentation, evaluating components and materials against restricted substance lists, and collaborating...

Job Title: Senior Regulatory Affairs SpecialistOverviewKamet Consulting Group is a leading management consulting firm serving the life sciences industry. We are currently seeking an experienced Senior Regulatory Affairs Specialist to join our team.Key ResponsibilitiesMonitor and analyze regulatory changes, trends, and developments in the pharmaceutical and...

Job DescriptionIn this vital role, you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision)...

Job DescriptionRoles & Responsibilities:- Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric...

Job Overview:The position of Global Regulatory Writing Manager is a leadership role that oversees the development and submission of regulatory documents. This includes Clinical Study Reports, Investigator Brochures, and other critical documents.This key leader will guide a team of writers to ensure timely completion of high-quality documents. A strong...

Job Title Regulatory Affairs Specialist - II-ETJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level AssociateAt Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to...