Apply on Employer Site

Abbott · 7 hours ago

Sr. Regulatory Affairs Manager

Lake Forest, IL

Full-time

Onsite

Mid, Senior Level

$111K/yr - $223K/yr

6+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Sr. Regulatory Affairs Manager will provide regulatory affairs project management and develop strategies to ensure the introduction of products into markets, while maintaining compliance with regulatory requirements.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Provide regulatory affairs project management for various areas, to include 510(k), CLIA Waiver, label/advertising/promotional review, and other regulatory compliance activities

In collaboration with the Regulatory leadership, develop and implement regulatory strategies that will ensure earliest possible introduction of product(s) into domestic and international markets

Coordinate preparation of well organized, complete and scientifically sound regulatory submissions

Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications

Exercise judgement within generally defined practices and departmental standard operating procedures

Develop and maintain strong and effective relations with internal/external personnel

Interacts with regulatory agency to expedite approval of pending registration

Serves as regulatory liaison throughout product lifecycle

Participates in some of the following : product plan development and implementation, regulatory strategy, risk management

Serves as regulatory representative to marketing, research teams and regulatory agencies

Advises development and/or marketing teams on manufacturing changes, technical labeling, appropriate regulations and interpretations

Keep abreast of regulatory requirements in the US and countries where the Division intends to offer product for sale

Work with the Regulatory leadership to prepare regulatory plan/strategy for product introductions

Manage the preparation of registration documents as required for international markets

Ensure that submissions are complete, properly formatted, and comply with applicable regulatory requirements

Make certain that appropriate documentation is maintained to record regulatory decisions made in design and development activities

Qualification

Regulatory AffairsRegulatory SubmissionsProject ManagementMolecular AssaysLateral Flow AssaysLeadership CompetencyInterpersonal SkillsNegotiation Skills