Compliance Specialist - Exempt
LanceSoft Inc
Join our team as a Compliance Specialist in beautiful Northridge, CA, where you will play a vital role in ensuring the safety and compliance of our medical devices. This position offers a flexible hybrid work schedule, allowing you to enjoy the vibrant local community while contributing to impactful projects.
Key Qualifications- Experience with medical device recall/field corrective actions and a strong understanding of FDA/international regulations.
- Proficiency in data analysis and reporting for recalls.
- Exceptional critical thinking, attention to detail, and effective communication skills.
- Prepare product bounding/scoping, tracking, and execution for medical device recalls.
- Collaborate with various departments/teams to gather recall-related information, prepare documentation, maintain records, and resolve issues.
- Document and analyze recall data and prepare reports for internal stakeholders and regulatory agencies, in accordance with regulatory requirements.
- Develop, implement, administer, and certify compliance policies, procedures, and practices.
- Ensure alignment with legal and ethical standards of the organization.
- Provide compliance advice, investigate complaints, and verify deficiencies are corrected.
- Develop employee communication and training programs focused on the elements of a companywide compliance program.
- Enforce antibribery and anticompetition laws.
- Analyze metrics and audit functional compliance programs.
- Maintain current knowledge of laws for financial, advertising, and marketing reporting, regulations, and industry guidance that impact the company's compliance program.
- Bachelor's degree (preferred in Life Sciences/Engineering).
- 2-5 years of relevant experience.
- Preferred onsite (hybrid) in Northridge, CA with flexible 3 days onsite, 1st shift.
Vacancy posted 2 days ago
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