Compliance Officer at Silverwave Corporation

Regulatory Compliance Monitoring: Ensure that company products and processes meet all relevant FDA regulations, including those for manufacturing, labeling, packaging, marketing, and distribution.
Documentation and Record Keeping: Maintain accurate and detailed records of all compliance-related activities, including audits, inspections, and product reviews.
FDA Regulations Knowledge: Stay current with changes to FDA regulations, guidance documents, and industry best practices. Advise senior management on any impacts to operations.
Audit and Inspection Support: Lead internal audits to assess compliance with FDA requirements. Assist with external FDA inspections and provide necessary documentation to demonstrate compliance.
Corrective Actions: Investigate non-compliance issues and recommend corrective and preventive actions. Work with cross-functional teams to implement solutions and ensure compliance moving forward.
Product Labeling Review: Ensure that product labeling meets FDA requirements, including proper claims, ingredient lists, safety warnings, and instructions for use.
Training and Education: Develop and conduct training for internal teams regarding FDA regulations, compliance procedures, and any updates to requirements.
Reporting and Documentation: Prepare and submit required regulatory reports and documentation to the FDA, ensuring they are accurate and timely.
Risk Assessment: Evaluate potential risks related to FDA compliance and provide strategies to mitigate those risks.
Collaboration: Work closely with Quality Assurance, Legal, R&D, and other departments to ensure cross-departmental compliance with FDA regulations.
Regulatory Submissions: Support the preparation and submission of regulatory filings to the FDA, such as 510(k), NDA, or other relevant applications.

Education: Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field. A Master's degree is a plus.
Experience: Minimum of 3-5 years of experience in FDA compliance, regulatory affairs, or a related field within the healthcare, pharmaceutical, or biotechnology industries.
Regulatory Knowledge: Deep understanding of FDA regulations (CFR Title 21, FDA guidance documents) and how they apply to products and manufacturing processes.
Attention to Detail: Strong ability to interpret and apply complex regulations while maintaining accurate and organized records.
Communication: Excellent verbal and written communication skills to clearly present compliance findings and interact with internal teams and external regulatory bodies.
Problem-Solving: Strong analytical skills to identify issues, analyze potential risks, and recommend corrective actions.
Project Management: Ability to manage multiple compliance projects simultaneously while adhering to deadlines.
Software Proficiency: Familiarity with regulatory management software, document control systems, and general office software (Excel, Word, etc.).