A company is looking for an Associate Director, Regulatory Affairs and Submissions. ...
Remote-Medical Device Regulatory Affairs Specialist II. ...
A company is looking for a Senior Manager, Regulatory Affairs IVD & CDx. ...
You will lead the Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be responsible for developing and executing regulatory strategies for drug development and commercialization ensuring compliance w...
A company is looking for a Senior Analyst, Regulatory Affairs to join their Corporate Counsel team. ...
The Executive Director, Regulatory Affairs will develop and execute global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease ensuring fast to market global product registrations, product promotion, maintenance of products and processes in regulato...
Senior Regulatory Affairs Specialist – Structural Heart (on-site) page is loaded Senior Regulatory Affairs Specialist – Structural Heart (on-site) Apply locations United States - Minnesota - St. Master’s Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience. ...
Principal Regulatory Affairs Specialist - Electrophysiology Pulsed Field Ablation. Minimum of 7 years of regulatory affairs or related experience, or 5 years’ experience with an advanced degree (Master’s or PhD). Regulatory Affairs, Medical Research, Clinical Research, Compliance, Medical Device, Le...
Masters Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience. We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team on-site in St. Assist in the development of regional regulatory strategy and update strategy based upon regulatory...
About this role:The Senior Regulatory Specialist is responsible for activities which lead to and maintain regulatory approval to market devices. A minimum of 5 years of regulatory affairs or related experience. Additionally, the Specialist is responsible for assessment of device changes for regulato...
Regulatory Affairs Specialist III. The individual will apply basic regulatory understanding to support of product and teams as well as prepare US/CE regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Additionally will handle regulator...
The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings. This position will demonstrate advanced knowledge of regulatory changes and assist with communication to customers and regulatory authorities. Assist with regulatory respo...
The International Regulatory Affairs Specialist provides regulatory support for implantable neurostimulation therapy for the treatment of obstructive sleep apnea. Interact with international regulatory partners in local offices to support submission contents, as well as foreign regulatory agency rev...
The Business Relationship Manager (BRM) will co-create, own, and drive the global IT strategy for the assigned Quality Assurance and Regulatory Affairs (QARA) business domains in alignment with the overall strategy and under guidance of the Lead BRM. IT experience, with minimum 5 years of experience...
Regulatory Affairs Manager, Advertising & Promotions. Ethical guidelines of the regulatory profession, clinical research and regulatory process. Maintain current knowledge of the applicable regulatory requirements and assess potential risk and impact to the advertising & promotional processes. Devel...
The Senior Medical Safety Specialist works with minimal supervision on a range of medical safety activities of varying complexity in collaboration with Medical Safety team members and other functions, including Regulatory, Quality/Post-Market vigilance, Risk Management, Complaint Handling, Product D...
Remote-Medical Device Regulatory Affairs Specialist II . As a Regulatory Affairs Specialist II you will:. Work with the international regulatory affairs group to ensure products are registered globally based on the spinoff strategy. Field requests from global regulatory associates for registrations,...
Regulatory Affairs Operations Specialist I. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifi...
Medtronic Structural Heart is seeking an experienced and highly motivated Senior Manager of Regulatory Affairs to play a crucial role in the development and execution of global regulatory strategies for innovative transcatheter valve technologies. Senior Manager, Regulatory Affairs - Structural Hear...
Maintain Regulatory Affairs product files to support compliance. Author and prepare regulatory submissions for new products and changes. Review significant regulatory issues with supervisors and resolve submission issues. Develop regulatory strategies and provide ongoing support to project teams. ...
Regulatory Affairs Specialist - Medical Device. Provide strategic input and technical guidance on regulatory requirements for product modifications. Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements. ...
Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams. The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory prod...
Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams. The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory prod...
Remote-Medical Device Regulatory Affairs Specialist II . As a Regulatory Affairs Specialist II you will:. Work with the international regulatory affairs group to ensure products are registered globally based on the spinoff strategy. Field requests from global regulatory associates for registrations,...
You will be responsible for managing a small team overseeing the mechanical heart valve and annuloplasty ring product portfolio, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, compiling regulatory submissions, and ensuring data is effectively...