Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Branchville, NJ 07826
About the Job
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.
- 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.
Source : Katalyst Healthcares & Life Sciences
