Regulatory Specialist: salario promedio en San Mateo, CA in 2024
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Clinical Research Regulatory Specialist
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...
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 ...
Senior Quality Regulatory Specialist
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. ...
Staff Quality Specialist - Regulatory Compliance
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 ...
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...
Regulatory Affairs Specialist IV
A medical device client of ours in the East Bay Area is looking to bring on a Regulatory Affairs Specialist IV position!. Years of Regulatory Affairs experience across the medical device space. International Regulatory Affairs Experience Required (Europe specifically). ...
Regulatory Affairs Specialist
Assist Regulatory Management with product deviation reporting to the FDA. Advanced understanding of Good Manufacturing Practices (GMPs), FDA & EU Regulatory requirements. ...
Regulatory Specialist
Collaborate with cross-functional teams to drive regulatory project management activities. Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices. Collaborate with external partners including regulatory agencies, authorized represent...
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...
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...
Principal Regulatory Affairs Specialist – US New Product Introduction – Diabetes Care (on-site)
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 ...
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...
Compliance Risk Specialist, Third Party Regulatory Oversight, Issue Management & Risk and Controls
Ensure regulatory change management is occurring through SoFi’s third party providers and are included in SoFi’s regulatory change management repository per the regulatory change management policy. The primary function of this position is to support the Compliance department in the development and i...
Senior Regulatory Affairs Specialist
With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs. Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files. Candidate expertise includes det...
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
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:. ...
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 / Clinical Affairs Specialist
Leor Weinberger, director of the Gladstone-UCSF Center for Cell and Viral Circuitry, seeks a highly motivated Regulatory / Clinical Affairs Specialist to manage regulatory affairs, author and assemble IND applications, and help manage FIH studies on new antiviral gene therapeutic candidates. The pos...
Program Manager (Amend)
Amend is seeking at least one Program Manager who will be central to the planned expansion of the Amend program in new states and women's prisons. The Program Manager will be assigned a broad spectrum of analytical, management, curriculum support, and program development duties that will require kno...
Future Opportunities - Join Our Talent Pipeline for Manager/Sr. Manager, Global Regulatory Affairs S
Global Regulatory Affairs Strategy roles (U. Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Assist Re...
Engineering Project Manager
We are seeking a hands on engineering Project Leader to champion the hardware implementation of ground-breaking wireless charging systems for electric vehicles! In this pivotal role, you will collaborate with engineering teams and program managers to bring innovative charging solutions to life acros...
Senior Quality Assurance Specialist
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...
Associate Director, Regulatory Affairs: Job ID - 1435
The Associate Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-...
Manager, Global Regulatory Affairs
We are seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). Combination of the following can be considered: PhD or PharmD with 2+ years of pharmaceutical industry experience in regulatory affairs; MS with 4+ years; BS with 5+...