As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization. Strong understanding of Regulatory Operations processes and systems including Regulatory Information Management & Document/ Da...
Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Participate in the development of regional regulatory strategy and update strategy based on regulatory changes. A minimum of 5 years of experience in medical d...
We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Assist with the collection, c...
The Principal Regulatory Affairs Specialist will combine knowledge of scientific, regulatory, and business issues to enable products that are developed to meet required regulatory requirements. The Principal Regulatory Affairs Specialist will also provide effective direction and guidance to R&D,...
The Staff/Principal Regulatory Affairs Specialist will function as a subject matter expert and will be part of a high-performing RA team and responsible for contributing to the development of regulatory strategies, preparing U. Represent regulatory in clinical program teams and communicate regulator...
The Principal Regulatory Affairs Specialist hired will report to the Senior Director of Regulatory and Quality, with sights to build out an RA team as needed. Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance ...
Regulatory Affairs Specialist III in Pleasanton, CA. Your main responsibilities as a Regulatory Affairs Specialist III:. May review, interpret, and report Regulatory leadership on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer...
Our client, a large healthcare company is seeking a Regulatory Affairs Specialist to join their team! As the Regulatory Affairs Specialist you would provide regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensu...
We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Assist with the collection, c...
Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Participate in the development of regional regulatory strategy and update strategy based on regulatory changes. A minimum of 5 years of experience in medical d...
As a Senior Regulatory Affairs Specialist, Medical Devices at Verily, you will work directly with other Regulatory Affairs team members, partners, and a team of experts from diverse fields (eg, Biology, Chemistry, Physics, Electrical Engineering, Computer Science) to develop, manage and execute regu...
Required Skills:Regulatory Escalations Specialist Responsibilities:Serve as an expert on enforcing Meta’s Community standards and policies, including regulatory policies and region specific social media legislation where required. Summary:Meta is seeking an Escalations Specialist to join the Detecti...
Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. Key job respon...
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.Ardelyx has two commercial products approved in the United States, IBSRELA®(tenapanor) and XPHOZAH® (tenapanor), as well as early-stage pipeline ca...
The Principal Regulatory Affairs (RA) Specialist will work with the team to support the Regulatory Affairs department to ensure the overall regulatory compliance with the applicable regulatory bodies and ensure compliance with the Presidio Quality Management System (QMS). The Principal Regulatory Af...
Collaborate with cross-functional teams to drive regulatory project management activities. Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices. Collaborate with external partners including regulatory agencies, authorized represent...
Senior Regulatory Affairs Specialist . Senior Regulatory Affairs Specialist. Provides regulatory input and technical guidance on global regulatory requirements to product development teams. Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team. ...
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.Ardelyx has two commercial products approved in the United States, IBSRELA®(tenapanor) and XPHOZAH® (tenapanor), as well as early-stage pipeline ca...
With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs. Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files. Candidate expertise includes det...
Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements. Principal Regulatory Affairs Specialist. Proven expertise in all aspects of Regulatory Affairs; Strat...
Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. Acts as a regu...
Senior Staff Regulatory Affairs Specialist. Senior Staff Regulatory Affairs Specialist. You will be responsible for regulatory agency communications regarding pre-submission strategies/ regulatory pathway development and submission. Serve as a regulatory affairs representative to improve awareness, ...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Assist with the collection, c...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...