Manager Regulatory Affairs, In Vitro Diagnostics and Companion Diagnostics (Remote)

Updated: April 24

Irvine

Expired

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84.6

6mi

Job Abstract

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.

Qualifications

Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related subject
Preferred Education: Relevant advanced degree preferred. Certification a plus.
Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems
Preferred Experience: 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing
Experience working in a complex and matrix environment
Strong oral and written communication skills
Note: Higher education may compensate for years of experience

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.?
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.?
This job is eligible to participate in our short-term incentive programs. ?
This job is eligible to participate in our long-term incentive programs?

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

Search Terms: Diagnostic, Regulatory Affairs, Manager, Regulatory, Companion

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