Under the direction of the Clinical Research Manager, and in compliance with University and Department policies and federal and state regulations, the Regulatory Specialist will work closely with investigators, their study teams, regulatory personnel, and sponsor partners to draft and manage study d...
The Ambulatory Regulatory Compliance Specialist has a pivotal role within the organization and is responsible for ensuring adherence to regulatory standards across diverse areas. The Ambulatory Regulatory Compliance Specialist has a pivotal role within the organization and is responsible for ensurin...
The Department of Orthopaedic Surgery is looking for a candidate experienced in high volume clinical trials, protocol development, and regulatory submissions to work with investigators to prepare, submit, provide guidance, and manage the regulatory submissions. Under the direction of the Research Ad...
A leading provider in the health care and digital health space is seeking a Senior Regulatory Affairs Specialist to join their regulatory team. As a key player in regulatory oversight, you will help ensure product compliance with global regulatory standards, including ISO 13485 and FDA regulations. ...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...
Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Review reports of customer complaints and assess them for regulatory reporting. ...
Senior Regulatory Affairs Specialist. Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings. Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions. Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK ...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 - $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
Rhythm is currently seeking an experienced & motivated Staff Quality Specialist - Regulatory Compliance based remotely. You are a passionate quality or regulatory compliance professional with at least 8 years of experience in a Quality or Regulatory related role. Build cross-functional partnerships ...
The Regulatory Specialist is a part of Research and Development, this team is responsible for assessing ingredient safety and regulatory compliance, coordinating safety, micro, stability, compatibility and claims testing, ensuring product compliance with international cosmetic regulations, and advis...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a. Principal Biologist/Regulatory Specialist, Power and Renewables. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental i...
Senior Regulatory Affairs Specialist - Remote Based - West Coast. This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives. Confer with other Regulatory Affairs subject matter exp...
As a Senior Global Regulatory Specialist at Eko, You Will:. Assist/lead global regulatory submissions and build regulatory guidance and strategy. As a Senior Global Regulatory Specialist at Eko, You Have:. Regulatory/Global Regulatory Affairs for medical devices, and/or software as a medical device ...
This Principal International Regulatory Operations Specialist will work on-site at our Alameda, CA location in the Diabetes Care Division. As an individual contributor, the Principal Specialist will provide support for the regulatory department to ensure efficient and compliant business processes an...
Provides consultation/advice to regulatory specialist for change control and product development. Exempt/Non Exempt: Non Exempt Years Experience: - years regulatory experience and/or years relevant industrial experience typically with a quality, product-development/support, or scientific affairs fun...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
Assist Regulatory Management with product deviation reporting to the FDA. Advanced understanding of Good Manufacturing Practices (GMPs), FDA & EU Regulatory requirements. ...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a. Principal Biologist/Regulatory Specialist,. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
The responsibilities of a Senior Regulatory Specialist in the energy sector will vary depending on the specific company, sector (e. Responsibilities typical of a Senior Regulatory Specialist in the energy sector are provided below. Regulatory Compliance - knowledge of federal and municipal regulatio...
Principal International Regulatory Operations Specialist. As an individual contributor, the Principal Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment. Assist in the development of regional regulatory strategy and upda...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a. Principal Biologist/Regulatory Specialist,. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information. Anticipate regulatory obstacles and ...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Regulatory Affairs Specialist II:. ...
Responsible for regulatory activities, including product registrations, regulatory impact. ...