Regulatory Affairs Specialist III – Global Submissions. As a Regulatory Affairs Specialist III at Thermo Fisher Scientific Inc. This is a world-class position where you will collaborate with Regulatory Project Leads to prepare flawless regulatory submissions and ensure their timely delivery to globa...
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...
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 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:. ...
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...
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...
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. ...
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...
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 ...
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...
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. ...
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...
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...
The Manager, Regulatory Affairs, is responsible for leading Carlsmed’s regulatory submissions and successfully interacting with regulatory agencies. Lead the Regulatory Affairs function, including creation and/or oversight of US and International regulatory submissions. Represent Regulatory Af...
The Equipment Installation/Space Modification Project Manager oversees planning, design review, cost estimation, scheduling, coordination, and execution of space modification and equipment installation projects. The Project Manager should have knowledge of computer based data and project management ...
As the Project Manager, AI Software you will be responsible for utilizing the Agile development approach to design product-level requirements, create and manage the product backlog, and collaborate closely with the development team to ensure the successful and timely delivery of the AI product roadm...
Reporting to the Senior Director of Regulatory Affairs, the Manager/Senior Manager, Regulatory Affairs will be responsible for strategic and administrative aspects of regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of highest quality, and ...
As a WendWell Health Distributor/Agency - Sales Team Manager, you will lead your team of agents dedicated to promoting and enrolling eligible customers into Affordable Care Act (ACA) healthcare plans. Training and Compliance: Conduct comprehensive training programs for new and existing agents, focus...
Furthermore, the Deputy Project Manager will assist in coordinating utility and local facility relocations impacted by the Authoritys project. Under the general direction of the Supervising Transportation Engineer (Sup TE), the Licensed Engineer will serve as the Deputy Project Manager. The Deputy P...
Project Manager, Program Manager leading large teams and complex projects. The Senior Program Manager position is a key role in Atom’s Cloud Transformation Practice. As the Senior Program Manager, you'll be tasked with leading mission-critical projects and driving enterprise transformations within O...
Senior Quality Assurance Specialist – Southern California, $90K-$100K. I’m currently partnered with an innovator in connectivity solutions, who are looking for a Senior Quality Assurance Specialist. In this role, you'll play a key part in ensuring compliance with ISO 9001 standards, collaborating ac...
Quality Management Systems experience (up to and including ownership of a quality system element, implementation of a quality system element) . The primary focus of this role is the support and oversight of Quality Management Systems ensuring key requirements and initiatives are implemented, main...
Ensures that contractor is performing quality assurance (QA) of stored petroleum products, maintaining quality standards in compliance with MIL-STD 3400-C. The incumbent is the Quality Assurance Evaluator (QAE) for the alongside aircraft refueling contract. The incumbent is responsible for insuring ...
Right At School works to develop in children the traits that are not only important during their youth, but which will lend to their lifelong success! These traits are embedded in our curriculum, our instructional methods, and our positive guidance approach! Our Program Managers focus on helping chi...
The Associate Director / Director of Regulatory Affairs will help develop regulatory strategy and be an active partner in drug development project planning and execution. ASSOCIATE DIRECTOR / DIRECTOR OF REGULATORY AFFAIRS -. Effectively coordinate with Regulatory Operations to ensure on-time prepar...