Manager Regulatory Affairs, In Vitro Diagnostics and Companion Diagnostics

Found in: Resume Library US A2 - 2 weeks ago

Irvine California, United States AbbVie Full time
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.

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