Compliance Specialist

Job Overview:

Pay Range: $25.00hr - $30.00hr

Requirement/Must Have:

• Minimum Bachelor Degree BS degree in Engineering, Physical or Biological Science, or other technical field.
• 4+ years experience in product quality or regulatory compliance (or combined experience) in the medical device or other regulated industry.
• General understanding of applicable US medical device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO 14971), and international regulations (e.g., CMDR Canada, XX, RDC Brazil).
• Experience with computer regulations/standards and methodologies.
• Strong organizational, written, and verbal communication skills.
• Critical thinking skills and proficiency in constructive dialogue.
• Effective at prioritizing tasks and responsibilities within a fast-paced, dynamic environment.
• Effective in collaborating and partnering with field action team and displaying an appropriate level of assertiveness.

Responsibilities:

• Process and reconcile customer returned acknowledgement forms per regulations and internal procedures.
• Provide guidance to customers for product recall related questions.
• Help provide updates on effectiveness levels for each field action.
• Assist in preparing monthly regulatory reports on field action effectiveness status.
• Manage the recalls inbox and complete requests as needed.
• Assist in providing status updates to cross-functional teams when needed.
• Assist with providing information to Audit Management on maintaining audit readiness for internal and external audits.
• Perform assessments, develop action plans, and drive plans to effectively manage recall inbox and address any urgent communication appropriately.
• Collaborate in development, maintenance, and improvement of processes and procedures for various processes within the quality management system.
• Coordinate and assist field action team related activities.
• Ensure appropriate processing of customer acknowledgement forms and inquiries related to field actions.
• Collaborate with business partners and management to address customer escalation concerns as they relate to field action.
• Assist the team in record retention based on company and regulatory standards.

Nice to Have:

• Experience working directly with the FDA, Notified Body, or other governmental agencies.

Skills:

• Product Quality.
• Regulatory Compliance.
• Medical Device Regulations.
• 21 CFR Part 820.
• 21 CFR Part 11.
• ISO 13485.
• ISO 14971.
• CMDR.
• RDC.
• Quality Management System.
• Audit Readiness.

Qualification And Education:

• Bachelor of Science degree in Engineering, Physical or Biological Science, or other technical field.

 

Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.

About Cynet Systems

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.

As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.