Regulatory Affairs Specialist
2 weeks ago
Job Title: Regulatory Affairs Specialist
Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at GForce Life Sciences. The ideal candidate will have a strong background in regulatory compliance and quality systems.
Key Responsibilities:
- Implement and maintain quality systems to ensure compliance with regulatory requirements.
- 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 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.
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.
Education and Experience: Bachelor's degree preferred in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, or related field. 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.
Work Environment: This is a full-time position that requires on-site work in Alameda, CA, 5 days per week. Must be able to work on a W2. We offer a competitive salary and benefits package.
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