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The Program Manager 2 will be responsible for managing a subset of the F-35 Support Equipment portfolio in the acquisition of fleet support equipment in all phases of program life cycle; proposal development, negotiation, startup, execution, and completion (contract closeout).
Leading cross-function...
AbbVieIrvine, 32 mi from Los Angeles
Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent quality oversight of GxP activities, covering...
Aequor Technologies LLCThousand Oaks, 41 mi from Los Angeles
FULLY REMOTE
The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases...
Allergan AestheticsIrvine, 32 mi from Los Angeles
Job Description
Description
The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team.
Plans...
Aditi ConsultingThousand Oaks, 41 mi from Los Angeles
Summary:
The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases...
Ampcus IncorporatedThousand Oaks, 41 mi from Los Angeles
What we are looking for:
Desire to learn Regulatory Affairs CMC and global submission strategy
Strong organizational skills with attention to detail
Proficient time management skills and ability prioritize workload
Ability to work both...
RAND CorporationSanta Monica
Safety & Emergency Program Manager. The Safety & Emergency Program Manager assists in the administration of a wide variety of safety functions and emergency management tasks across the RAND world-wide enterprise. Reporting to the Manager, Security, Intelligence, and Risk Management, the.
Oversee the...
Nihon Kohden AmericaIrvine, 32 mi from Los Angeles
The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization’s products.
Work with RA Leadership...
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Manager Regulatory Affairs, In Vitro Diagnostics and Companion Diagnostics (Remote)
AbbVie | Irvine | www.resume-library.com |
Job Description
The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives.
Supports regulatory objectives for the management of IVD/CDx global submissions under limited management supervision. Develops and manages content strategy for regulatory submissions including technical files for CE marking, US PMAs, US IDEs, US 510(k), DE NOVO 510(k) and other relevant submissions.
Builds and maintains relationships with relevant stakeholders including Regulatory Affairs functional areas, Precision Medicine, Medical Affairs and Commercial organizations. Represents CDx Device RA on teams to negotiate, influence and provide strategic advice to internal and external stakeholders.
Responsibilities:
Develops device regulatory product strategies and identifies data and information requirements with limited supervision.
Assists with preparation of submissions, supplements, and correspondence with regulatory authorities, including Performance Evaluation Applications under IVDR, requests for Study Risk Determinations and Investigational Device Exemption (IDE) applications.
Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
Seeks expert advice and technical support as required for strategies and submissions.
Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions.
Represents RA Device on product development teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.
Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation and guidance and provides updates to organization under limited supervision.
Develops, implements, and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to Device RA.
This role can be based remotely anywhere within the U.S.
The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives.
Supports regulatory objectives for the management of IVD/CDx global submissions under limited management supervision. Develops and manages content strategy for regulatory submissions including technical files for CE marking, US PMAs, US IDEs, US 510(k), DE NOVO 510(k) and other relevant submissions.
Builds and maintains relationships with relevant stakeholders including Regulatory Affairs functional areas, Precision Medicine, Medical Affairs and Commercial organizations. Represents CDx Device RA on teams to negotiate, influence and provide strategic advice to internal and external stakeholders.
Responsibilities:
Develops device regulatory product strategies and identifies data and information requirements with limited supervision.
Assists with preparation of submissions, supplements, and correspondence with regulatory authorities, including Performance Evaluation Applications under IVDR, requests for Study Risk Determinations and Investigational Device Exemption (IDE) applications.
Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
Seeks expert advice and technical support as required for strategies and submissions.
Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions.
Represents RA Device on product development teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.
Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation and guidance and provides updates to organization under limited supervision.
Develops, implements, and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to Device RA.
This role can be based remotely anywhere within the U.S.
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