Register
Recruit Create CV

Regulatory Affairs Jobs in Sacramento, California

California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Vp Quality And Regulatory Affairs
By Proven Recruiting At San Diego, CA, United States
Management review of quality and regulatory team.
Manage the preparation and development of regulatory submission packages.
Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
Prior experience authoring and filing of regulatory documents.
Responsible for regulatory submission strategies to support product development and approval of various medical device products.
Interface with regulatory authorities and internal technical teams on regulatory submissions.
Regulatory Affairs Program Manager, Us
By ZEISS Group At Dublin, CA, United States

The Regulatory Affairs Program Manager US is responsible for developing and monitoring regulatory submission timelines for a variety of US medical device submissions (such as 510(k)s, IDEs and/or ...

Regulatory Affairs Analyst Jobs
By San Jose Water At San Jose, CA, United States
Required Knowledge Skills & Abilities
· Working knowledge of statistics, investments, budgeting, project management and computerized applications.
· The Regulatory Affairs Analyst requires substantial technical skill in finance, economics, and statistics.
· Utility rate-making methodologies and legal requirements.
· Excellent written and oral communication skills.
· A bachelor's degree or equivalent in finance, economics, accounting, engineering or a closely related field.
Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121 $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Senior Manager Regulatory Affairs
By Jasper Therapeutics At Redwood City, CA, United States
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
Must be able to effectively identify data needs, and successfully present to management.
Manage/track regulatory submission documents and timelines, collaborating with Clinical Operations and CROs to ensure timely submissions of all deliverables.
Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
Maintain up-to-date knowledge of current regulations for applicable territories. •
Other tasks and responsibilities as directed by the Regulatory Affairs leadership team.
Senior Regulatory Affairs Specialist
By NuVasive, Inc. At , San Diego $96,000 - $160,000 a year
Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
Knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.
This position is remote eligible, but we prefer candidates commutable to our San Diego, CA office
Ability to determine, communicate and make recommendations for submission and approval requirements to others
Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs
Understanding of regulatory terminology, pre-market submission types, and requirements
Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121, Ca $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Regulatory Affairs Consultants Jobs
By Pharmatech Associates, a USP company At San Francisco, CA, United States
Develop, lead, and drive the execution of the regulatory strategy from pre-IND to launch, commercialization and product lifecycle management
Responsible for communicating business-related issues or opportunities to next management level
Plan and oversee activities in support of all regulatory submissions
Provide regulatory guidance to the Client across all areas of regulatory affairs throughout all stages from product development
Participate as part of internal regulatory team to define and execute the regulatory strategy
Support the preparation of briefing packages, and regulatory submission documents as needed , providing insight and expertise
Regulatory Affairs Manager Jobs
By Ardelyx, Inc. At Fremont, CA, United States
Develop and maintain knowledge of regulatory requirements and industry trends independently and with line manager.
Ability to interpret and understand regulatory and cGXP requirements and apply to regulatory submissions and job duties.
Experience in FDA CMC submissions utilizing eCTD format and electronic submissions.
Proficient in Microsoft Suite products, experience with VEEVA RIM preferred.
Ability to independently manage timelines in a project team environment.
Maintain awareness of and expertise in FDA and ICH guidelines related to regulatory topics.
Senior Regulatory Affairs Associate/Specialist
By SciPro At San Diego, CA, United States
Be able to provide support to regulatory management and project teams and implement regulatory strategy while delivering documentation on time.
Maintain and manage databases containing regulatory information, submissions, and correspondence.
BS in life sciences with a minimum of 3 years of experience in Regulatory Affairs
Experience submitting IND filings utilizing eCTD formatted submissions highly desirable.
Independently plan daily work to complete time-sensitive assignments while following general instructions for project completion.
Review documents necessary for the regulatory site documentation related to the shipment of drug products to clinical sites.
Head Of Regulatory Affairs
By Life Science People At Torrance, CA, United States
Proven people management experience, with a track record of building and leading high-performing teams
Participate in the development and implementation of regulatory strategies to support product approvals, license maintenance, and lifecycle management
Collaborate with cross-functional teams to ensure that regulatory requirements are integrated into product development plans and timelines
Strong knowledge of FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs
Excellent writing, communication, and interpersonal skills
Prepare and maintain CMC documentation for various applications, including NDAs, DMFs, CEPs, INDs, etc.
Director Of Regulatory Affairs (Cell Therapy)
By GQR Global Markets At San Francisco Bay Area, United States
Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.
Depth Knowledge of GLP and GCP regulatory requirements in domestic and globally.
Manage all aspects of nonclinical and clinical regulatory strategy development for products (early- to late-stage/registration/post-market).
Prior experience with cell or gene therapies (preferred)
Prior experience in oncology drug development
10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
Regulatory Affairs Associate Jobs
By Intellectt Inc At Alameda County, CA, United States
May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices
Knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals.
Typically reports to a manager or head of a unit/department.
knowledge of FDA PMA guidance documents and CFR regulations.
In-House Counsel, Regulatory Affairs (Latin America)
By Astranis Space Technologies At San Francisco, CA, United States
Interface with foreign governments and regulators to manage the end-to-end satellite services licensing process
Manage the procurement of relevant landing rights for all of Astranis’s satellites
Excellent communication skills with legal and non-legal audiences
Preferred -- Experience working with telecommunications regulators in Latin America
Direct experience working with relevant national and international regulators
Prior experience working for a relevant satellite industry regulator
Regulatory Affairs Specialist Jobs
By Real Staffing At Irvine, CA, United States
Support 510(k) reviews (if sufficient experience)
Excellent verbal and written communication skills
Experience in a collaborative cross-functional development environment
Experience with FDA’s ecopy submission template a plus
Assist with 510(k) IDE drafting/compilation
Assist with 510(k) ecopy and submission
Vp, Regulatory Affairs Strategy
By Exelixis, Inc. At , Alameda, 94502, Ca $313,000 - $363,000 a year
Monitor current and proposed regulatory issues and trends and advise management on events of significance for Exelixis’ business interests.
Equivalent combination of education and experience.
Deep knowledge and understanding of the drug development process and regulatory requirements and environment
Strong interpersonal skills and the ability to skillfully and appropriately manage, develop and mentor personnel in a matrix environment
Provide Regulatory assessment to due diligence teams in terms of risks, requirements, and opportunities associated with potential in-licensed assets
Bachelor’s degree in related discipline and a minimum of twenty-one years of related experience; or,
Head Of Regulatory Affairs - Igt-D
By Philips At , San Diego, Ca
Extensive experience and knowledge required of global medical device regulations, requirements, and standards;
Leading strategic AOP management to optimize revenue
10 years of people management – with a strong track-record in successfully leading a Regulatory Affairs team
Experienced in strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities);
*Montana employees are currently excluded from this requirement at this time.
In return, we offer you
Regulatory Affairs Manager Jobs
By Leaman Life Sciences At San Francisco Bay Area, United States
Proven experience in regulatory management of centrally approved products
Manage the Labelling and packaging material supply
2-5 years of pharmaceutical industry regulatory experience
Experience in New Drug Applications
Experience in the preparation of CTAs to support clinical trials
Keep up to date with regulatory and legal changes across all markets
Regulatory Affairs Associate Jobs
By Select Source International At Alameda, CA, United States
Experience with global regulations and/or CE marking beneficial.
Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks.
Typically reports to a manager.
May lead and direct the work of others.
A wide degree of creativity and latitude is expected.
Job Title: Regulatory Affairs Associate