Regulatory Specialist: salario promedio en Napa, CA in 2024
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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 (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 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...
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. ...
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 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...
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
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:. ...
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...
Clinical Trial Regulatory Specialist I- Vallejo
The Clinical Trial Regulatory Specialist I (CTRS-I) is a novice level position which, under the direction of the KPNC Clinical Trials Compliance Director or designee and Principal Investigator (PI), provides regulatory document support to the Kaiser Permanente Northern California (KPNC) PI and resea...
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...
Manager/Senior Manager, Regulatory Affairs
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 ...
Senior Manager, Regulatory Affairs
Senior Manager, Regulatory Affairs (Clinical). Meet has partnered with an exciting late-stage oncology biotech that is looking for a Senior Manager of Regulatory Affairs to join their team. You will support the preparation of major regulatory submissions (IND's, NDA's, BLA's). You will serve as the ...
Regulatory Affairs Manager
Regulatory Affairs Manager - Permanent - Remote. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and p...
Regulatory Affairs Manager
The Senior Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U. Extensive knowledge of regulatory requirements, including ICH and regional guidelines, and an understanding of current global and regional trends in regulatory affai...
Executive Director Regulatory Affairs
The Executive Director/Senior Director of Regulatory Affairs will also oversee the preparation of all regulatory documents and submissions, mentor junior team members, and stay updated on changes in FDA and EU regulations. Executive Director/Senior Director of Regulatory Affairs. If you or someone y...
Privacy Program Manager
Privacy Program Manager to serve a leading tech company. Substantial experience as a privacy program manager. Work with privacy counsel to develop, implement, and maintain comprehensive privacy compliance programs and policies, including creation and updating of process documentation and operational...
Regulatory Affairs Manager
Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, CMC Regulatory Affairs, Biologics. ...
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...
Senior Construction Project Manager
The (Senior) Project Manager is critical to SEMA Construction’s corporate operations and involves oversight of a variety of projects. Senior) Project Manager - Heavy Highways & Bridges. Are you a Construction Project Manager with Heavy Highway and/or Bridge Construction experience looking to join a ...
Compliance Analyst, Senior - Privacy
The Senior Compliance Analyst has advanced knowledge of the job area and technical systems and practices, and advanced technical skills and reporting abilities. Maintains the compliance FWA audit program, including schedules, standards, processes, reports and tools in close collaboration with Compli...
Director/Sr. Director of Regulatory Affairs
Director of Regulatory Affairs. You’d oversee regulatory filings, partner with external consultants, and eventually build out the regulatory function internally. Partner with external regulatory consultants and oversee the build-out of the internal regulatory function. This role will be pivotal in b...
Regulatory Affairs Director
Regulatory Affairs Director required by Barrington James for an initial 12-month, remote contract opportunity with the client based in South San Francisco. ...