Job Description

Responsibilities

Implement and maintain the effectiveness of the quality system.

Support day-to-day manufacturing and operations activities related to change control.

Provide consultation and advice to regulatory specialists regarding change control and product development.

Offer regulatory direction and interpretation on team activities.

Apply regulatory knowledge to support product-related activities.

Prepare U.S. regulatory submissions and registration documents for international affiliates and government agencies worldwide.

Manage regulatory activities related to documentation, labeling, and field support

Apply regulatory and technical knowledge to complex work assignments.

Ensure compliance with the appropriate quality system for supported medical devices.

Maintain and demonstrate knowledge of site and division-level policies and procedures.

Stay informed about changes in regulations and standards affecting medical devices

Participate in audits and inspections as needed.

Contribute to continuous improvement initiatives within the regulatory affairs function.

Requirements:

7 years of regulatory experience 5 years of relevant industrial experience, typically within a quality, product development/support, or scientific affairs function.

Knowledge of regulations and standards affecting In Vitro Diagnostics (IVDs) and/or biologics.

Ability to interpret and apply regulatory requirements.

Strong communication and interpersonal skills.

Detail-oriented with excellent organizational abilities

Proficiency in Microsoft Office suite.

Collaborate effectively with cross-functional teams.

Ability to prioritize tasks and manage multiple projects simultaneously.

Job Tags

Permanent employment, Worldwide,

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