Regulatory Affairs Coordinator
5 hours ago
BioPhase Solutions is seeking a skilled Regulatory Affairs Specialist to join our team in San Diego, CA. As a key member of our organization, this role will focus on managing and maintaining documentation processes to ensure compliance with company policies and industry standards.
Responsibilities- Documentation Management: Coordinate the creation, review, approval, and archiving of controlled documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and other quality-related documentation.
- Document Control: Maintain and organize document control systems to ensure documents are current, accurate, and easily accessible.
- Regulatory Submissions: Support regulatory submissions by preparing and formatting required documents in compliance with applicable standards.
- Cross-Functional Collaboration: Collaborate with internal teams to ensure all document changes are implemented accurately and on time.
- Audit Preparation: Assist with internal and external audits by providing necessary documentation and ensuring readiness.
- Product Lifecycle Documentation: Support the team with the management of product lifecycle documentation, including revisions and updates to technical files.
- Education: Bachelor's degree (B.A. or B.S.) in a related field or equivalent work experience.
- Experience: Minimum 3 years of document control experience, preferably within the medical device or biotechnology industry.
- Knowledge: Familiarity with ISO 13485, FDA 21 CFR Part 820, or other quality system regulations.
- Technical Skills: Experience working with electronic document management systems (EDMS).
- Soft Skills: Strong organizational skills with attention to detail and accuracy, excellent communication and interpersonal skills for cross-functional collaboration.
The estimated salary range for this position is $23-$28 per hour, based on industry standards and market conditions in San Diego, CA.
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