Sr. Compliance Specialist
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Job Location:
Juncos - Puerto Rico
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Develop implement administer and certify compliance policies procedures and practices to ensure alignment with corporate legal and ethical standards.
Provide compliance guidance and advice to cross-functional teams ensuring adherence to internal and external regulations.
Investigate complaints and verify that identified deficiencies or nonconformities are properly corrected and documented.
Develop and deliver employee communication and training programs focused on company-wide compliance elements.
Enforce anti-bribery antitrust and competition laws maintaining ethical business conduct.
Conduct metrics analysis risk assessments and internal audits to evaluate and improve compliance program effectiveness.
Maintain current knowledge of applicable laws financial reporting rules advertising/marketing regulations and relevant industry guidance.
Collaborate with Quality Regulatory and Operations teams to ensure effective CAPA change control and validation processes.
Support and participate in regulatory and internal audits ensuring documentation accuracy and audit readiness.
Promote a culture of quality compliance and continuous improvement throughout the organization.
Perform other duties as assigned related to compliance and quality systems support.
Requirements
Education: Bachelors degree in Science or Engineering.
Experience: Minimum 68 years in a regulated industry (medical device strongly preferred).
Quality Systems Expertise: Proven experience in CAPA change control validations and quality system maintenance.
Regulatory Knowledge: Solid understanding of FDA 21 CFR Part 820 ISO 13485 EU MDR and related medical device regulations.
Audit Experience: Demonstrated participation in or leadership of regulatory and quality audits.
Technical Skills:
Proficiency in Microsoft Office Suite and Quality Management Systems (QMS).
Strong technical writing and documentation management capabilities.
Project Management: Ability to handle multiple priorities and deadlines efficiently.
Analytical & Problem-Solving Skills: Expertise in root cause analysis and implementation of corrective and preventive actions (CAPA).
Communication: Excellent verbal and written communication skills with the ability to work effectively across teams and with external stakeholders.
Leadership & Interpersonal Skills: Proven ability to influence cross-functional teams and maintain compliance integrity across departments.
Company Industry
IT Services and IT Consulting
Key Skills
- Abinitio
- Apprentice
- Dermatology
- Cost Estimation
- Data Networking
- Liaison
