Regulatory Affairs Specialist
Job Description : Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA
Must be able to work on a W2
Position : Regulatory Affairs Specialist
Employment Type : Contract
Years Experience : 2-5 years of regulatory experience and / or 2 years of relevant industrial experience, typically within a quality, product development / support, or scientific affairs function.
Skills Required :
- Knowledge of regulations and standards affecting In Vitro Diagnostics (IVDs) and / or biologics.
- Experience with Japanese and Chinese regulatory submissions
- Ability to interpret and apply regulatory requirements.
- Strong communication and interpersonal skills.
- Detail-oriented with excellent organizational abilities.
- Proficiency in Microsoft Office suite.
Education : Bachelor's degree preferred in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, or related field.
Duties and 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.
Additional Requirements :
- Collaborate effectively with cross-functional teams.
- 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.
- Ability to prioritize tasks and manage multiple projects simultaneously.
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