Team Lead-Regulatory Affairs - Bridgewater

As a Regulatory Affairs Specialist at Mass General Brigham, you will be responsible for ensuring compliance with regulatory requirements and maintaining an updated library of FDA regulations and guidance documents. · AUTHORS AND REVIEWS OF STANDARD OPERATING PROCEDURES,T techNICA ...

The Global Regulatory Affairs Device Lead will drive global regulatory strategies for medical device and combination products.We are seeking an experienced Regulatory Affairs professional with familiarity with international submissions from within a global healthcare organization ...

Ensure compliance to FDA and other applicable regulations as Regulatory Affairs Manager. · ...

This position involves regulatory affairs with Technical Files or equivalent in an R&D or quality position with hands-on experience in the preparation review and/or auditing of medical device DHFs Risk Management files and/or DMRs. · Must have knowledge of European/International ...

Monte Rosa Therapeutics seeks an experienced Director of Regulatory Affairs to lead global regulatory efforts across development programs in immunology. · ...

The Director, Regulatory Affairs will be responsible for the strategic leadership, · development and execution of science-based, solution-oriented, · and globally aligned regulatory strategies for the program(s) · under his/her accountability.This role serves as a key · regulator ...

The Regulatory Affairs Manager reports to the Director of Regulatory Affairs and is responsible for executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth's product and product dev ...

We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. · ...

Job summary · Regulatory Affairs Manager for medical devices company. · Partner closely with the Director of Regulatory Affairs to define and implement regulatory strategies. · Provide regulatory guidance during product development to ensure compliance. · ...

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. · ...

The Regulatory Affairs Manager is responsible for executing regulatory strategies and ensuring compliance with global regulations. They will lead the process to obtain and maintain market approval for DeepHealth's product and product development. · Oversee the day-to-day function ...

+Job Summary · The VP of Regulatory Affairs will lead create and drive the regulatory strategy for life cycle management activities for Vafseo Auryxia and early development programs. · ...

Monte Rosa Therapeutics is seeking an experienced Director of Regulatory Affairs to lead global regulatory efforts across development programs. · ...

The Regulatory Affairs Director will lead regulatory strategies for DeepHealth’s product development and commercialization.The position requires experience in regulated industries with knowledge of FDA Quality System Regulations and medical devices regulations. · Help develop glo ...

Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. · ...

Reporting to the Director of Regulatory Affairs,the Regulatory Affairs Manager is responsible for executing regulatory strategies ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth's product and product develo ...

We are seeking an experienced Regulatory Affairs leader to define regulatory strategy and lead IND execution for complex oncology assets. · A Boston-based, clinical-stage biotechnology company is developing next-generation precision oncology therapies. · This role is ideal for a ...

The Regulatory Affairs Manager is responsible for executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth's product and product development. · ...

The Director, · Regulatory Affairs will lead global · regulatory strategy for development-stage · neuroscience programs. · <li_annual bonus opportunity medical dental vision life and AD&D short term long term disability 401(K) plan with match stock options flexible non-accrual pa ...

The Director Regulatory Affairs will lead global regulatory strategy for development-stage neuroscience programs. · Works with the Sr Director to develop and direct innovative strategies in support of assigned portfolio projects. · Makes point of contact with FDA and supports coo ...

This job involves preparing regulatory submissions while ensuring compliance with current regulations. The specialist will maintain meticulous regulatory documentation. · Proficiency in Regulatory Documentation. · Strong understanding of Regulatory Compliance. · ...