A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products. CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required. ...
Remote-Medical Device Regulatory Affairs Specialist II. ...
A company is looking for a Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Cardiovascular). ...
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 Regulatory Affairs Senior Associate to support regulatory document management and clinical trial submissions. ...
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...
Regulatory Affairs Specialist II. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Acts as a regulato...
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...
We are currently hiring a **Regulatory Affairs Operations Specialist I** to work on-site at our St. 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 produ...
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...
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...
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 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...
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...
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. ...
Pharma and Personal Care – Regulatory Affairs Manager/ NA Regulatory Business Partner . Collaborate with global PPC and NA regulatory partners and Marketing & GTC teams to develop and execute regulatory intelligence programs that converts regulatory change information to actionable insights. Drive r...
Responsible for defining global regulatory strategies and submissions in support of new and existing marketing authorizations for the devices (incl. Provide technical and strategic input for regulatory decisions aligned with business strategy. Monitor, evaluate, and interpret all applicable regulato...
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...
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. ...
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...
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,...
Have a passion for regulatory affairs? Interested in medical software? Look no further! We are looking for a savvy and passionate Senior Regulatory Affairs Specialist to join our team here at Canon Medical! As the Senior Regulatory Affairs Strategist, you will champion U. Support legal/regulatory ac...
Build and drive a Quality and Regulatory framework and strategy for the LPG businesses that supports growth and compliance readiness. Ensure compliance to quality and regulatory system requirements ( FDA CFR 820, ISO 13485/9001, IVDR) to meet requirements of regulated and non-regulated sites/product...