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Ambulatory Regulatory Compliance Specialist - 132844
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...
Senior Regulatory Affairs Specialist (IVD)
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. ...
Regulatory Affairs Specialist
Job Description: Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA. Provide consultation and advice to regulatory specialists regarding change control and product development. Experience with Japanese and Chinese regulatory submissions. Ability to interpret and apply regulatory requir...
Senior Regulatory Affairs Specialist
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 ...
Regulatory Compliance Specialist
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...
Regulatory Specialist
Conducts work in compliance with cGMP, safety and regulatory requirements. ...
Regulatory Affairs Specialist
Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of dossiers and sub...
Program and Regulatory Specialist
Program and Regulatory Specialist. The Energy Commission seeks a Program and Regulatory Specialist to fill one position in the Special Projects Unit within the Fuels and Transportation Division. Under general direction of a Program and Project Supervisor, the Program and Regulatory Specialist will s...
Regulatory Specialist - R&D
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...
Principal International Regulatory Product Specialist – Diabetes Care (on-site)
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...
Senior Regulatory Affairs Specialist
Regulatory Affairs Specialist will be responsible for assisting and supporting core regulatory affairs activities for the business, in addition to supporting advertising, promotional and standards review. Provide expert regulatory advice during the product design and development phases, ensuring reg...
Regulatory Specialist II
Our client, the medical device manufacturing industry, is seeking a Regulatory Specialist II to join their team. Responsible for regulatory activities, including product registrations, regulatory impact assessments, etc. APAC regulatory submissions in Medical Devices or Pharmaceutical industries. ...
Senior Regulatory Specialist - Environmental
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. DUTIES AND RESPONSIBILITIES Regulatory Compliance - knowledge of fed...
Regulatory Affairs Specialist II – Heart Failure
As an individual contributor, this position performs 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 specifications. Prepares robust ...
Regulatory Affairs Specialist
Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Tasks include:o Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of ...
Regulatory Affairs Specialist II – Heart Failure (on-site)
As an individual contributor, this position performs 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 specifications. Prepares robust ...
Senior Regulatory Affairs Specialist
The Senior Regulatory Affairs Specialist will collaborate across teams to manage complaint reporting, support audits, and ensure compliance with EU MDR and other applicable regulatory standards. The Senior Regulatory Affairs Specialist will play a critical role in ensuring that the company’s medical...
Principal Regulatory Affairs Specialist – Heart Failure (on-site)
As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. Principal Regulatory Affairs Specialist. This position performs specialized level work assignm...
Regulatory Specialist II
Responsible for regulatory activities, including product registrations, regulatory impact. ...
Senior Regulatory Specialist - Environmental
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...
REGULATORY AFFAIRS SPECIALIST 3.
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...
Regulatory Specialist II
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...
Senior Specialist, Regulatory Affairs, Critical Care
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
Principal Regulatory Affairs Specialist
Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements. Principal Regulatory Affairs Specialist. Proven expertise in all aspects of Regulatory Affairs; Strat...
Regulatory Affairs Specialist
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:. ...