Sr. Publisher – 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 ...

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 ...

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 ...

In this role you be part of a Regulatory Affairs Team to develop and deploy innovative and compliant regulatory strategies across business and markets to achieve the highest standards for patient safety and product efficacy. · ...

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. · ...

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. · ...

Be part of a Regulatory Affairs Team to develop and deploy innovative and compliant regulatory strategies across business and markets to achieve the highest standards for patient safety and product efficacy. · Assist in the implementation of comprehensive regulatory strategies by ...

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 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 ...

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. · ...

We are seeking a Regulatory Affairs Consultant to prepare clinical and regulatory documentation for clinical trials and deliver consulting services to ensure that the company meets regulatory requirements. · ...

+Be part of a Regulatory Affairs Team to develop and deploy innovative and compliant regulatory strategies across business and markets to achieve the highest standards for patient safety and product efficacy.+Assist in the implementation of comprehensive regulatory strategies by ...

The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations. · Cross-functional Collaboration: Collaborate with R&D PPM (product and project manager ...

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 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 ...

The Regulatory Affairs Specialist supports the activities of the Regulatory Affairs Department in ensuring compliance with accreditation, licensing, and regulatory requirements. · This position assists with survey readiness, documentation management, · performance tracking, · and ...

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

Reporting to the Head of Quality, Regulatory, and Compliance, · the Director of Regulatory Affairs is responsible for executing regulatory strategies, · ensuring compliance with global regulations and leading the process to obtain · and maintain market approval for DeepHealth's p ...

We are looking for a Regulatory Affairs Specialist to join our team in Cambridge, MA. In this role you will assist in implementing comprehensive regulatory strategies by collaborating with regulatory subject matter experts (SMEs) to ensure alignment with company objectives and co ...

Beam is seeking a Manager Regulatory Affairs to progress a broad portfolio of advanced genetic medicines in a fast paced and dynamic biotech environment. · The person will be responsible for supporting the development and implementation of the global regulatory strategy for Beam ...