A company is looking for an Associate Director, Regulatory Affairs and Submissions. ...
The Deputy Director will lead the strategic and operational management of new product introduction, regulatory affairs, permitting, product certification, and market development, primarily for early adopter markets like the U. This role requires deep expertise in driving large-scale product rollouts...
A company is looking for a Senior Manager, Regulatory Affairs IVD & CDx. ...
The Director, Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Nonclinical and Clinical Modules for regulatory submissions to support Umoja's drug products including, DMF, IND and NDA/BLA applicat...
A company is looking for a Regulatory Affairs Senior Associate to support regulatory document management and clinical trial submissions. ...
The Regulatory Affairs Specialist will produce regulatory-compliant documents to support Inventprise’s vaccine programs and will be responsible for managing competing priorities across multiple programs. What the Role Offers - Regulatory Affairs Specialist. BS required and 2+ experience in reg...
Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance. Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory req...
An international medical devices manufacturer is seeking a Senior Regulatory Affairs Specialist to join their US team. Keep abreast of legislation, guidelines, and regulations relating to regulatory affairs in the US; inform and advise the team in Japan. Participate in medical, industrial activities...
Develop regulatory strategies and communicate risks within regulatory strategies vs project plan, and outline proposal for balancing the project risk to project teams and Regulatory Affairs Management. Reporting to the Director of Regulatory Affairs-Ultrasound, you will collaborate with regulatory A...
As part of a small, passionate, and accomplished team of experts in the Legal and Compliance Department, you will help shape the company’s regulatory affairs program. Beyond providing counsel as a subject matter expert in the areas described below, you will develop processes and tools to amplify the...
Deputy of Regulatory Affairs to be a part of the Regulatory Affairs Team. This position reports to a Vice President of Regulatory Affairs and provides management and support to the following areas: licensing; regulatory oversight; environmental, safety and health; training; corrective action; proces...
Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including Engineering, Product Management, Quality Compliance, Clinical Affairs and other functions at all levels within the business. Minimum of 8 years of experience in regulatory affairs, speci...
Work in collaboration with Bausch Health Group Promotional Review Committee Regulatory lead, ensuring regulatory compliance for Solta promotional materials and other promotional activities. Ensure all tracking including the Regulatory Approval Matrix is up to date for all product portfolio/SKU based...
Regulatory Affairs Program Manager III to become the newest member of our QA/RA Team located in Bothell, WA. The Regulatory Affairs Program Manager III is responsible for supporting the RA department in Bothell and in Burnaby, BC in the preparation and organization of documents supporting compliance...
Regulatory Affairs Specialist - Bothell, WA. Master’s Degree in Biomedical Regulatory Affairs, Biotechnology, or a related field and one (1) year of experience in position offered or related position including one (1) year of experience working in a medical device industry. Lead efforts in the prepa...
Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. Senior Regulatory Affairs Specialist. Serve as RA Repre...
Regulatory Affairs Specialist, Clinical Data Analyst, or similar regulatory compliance role. Federal Regulatory Affairs Coordinator - Swedish First Hill (Full Time, Day Shift). Swedish is seeking a full-time Federal Regulatory Affairs Coordinator - Prepares, facilitates, coordinates, and submits doc...
The Manager, Regulatory Affairs (CMC) is responsible for providing regulatory support and guidance on CMC -related submissions to the FDA and other regulatory authorities worldwide. Kelly® Science & Clinical is seeking a Manager, CMC Regulatory Affairs for a direct hire opportunity with one of o...
Director* of Regulatory Affairs. Act as the main point of contact for regulatory authorities, managing all communication, including pre-submissions, Q-subs, and meetings with regulatory bodies. Collaborate with clinical teams on regulatory submissions and trial designs, ensuring compliance with regu...
As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the market and ensure ongoing compliance. Assist in the development of regulatory strategy and updates strategy based upon regulatory changes. Prepare and submit electronic and paper regulatory...
Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including Engineering, Product Management, Quality Compliance, Clinical Affairs and other functions at all levels within the business. Minimum of 8 years of experience in regulatory affairs, speci...
We’re looking to hire a Director, Public Affairs Communications, Regulatory & Antitrust. As a member of the Public Affairs Team, you’ll also collaborate with colleagues focused on marketing, digital media, campaign management, and global government affairs, as well as communications colleagues aroun...
The Manager, Regulatory Affairs provides direct support to Solta operations for their globally distributed products. Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, com...
The Senior Manager, Regulatory Affairs is an individual contributor role that supports a senior regulatory professional by executing against the global regulatory plan for one or more products. This position represents Regulatory on cross-functional teams and leads the development and preparation of...
The Manager, Regulatory Affairs (CMC) is responsible for providing regulatory support and guidance on CMC -related submissions to the FDA and other regulatory authorities worldwide. Kelly® Science & Clinical is seeking a Manager, CMC Regulatory Affairs for a direct hire opportunity with one of ...