Senior Quality and Regulatory Specialist

Position Summary:

Fourth Frontier Technologies Private Limited is seeking a highly organized and detail-oriented Quality and Regulatory Specialist to support the ongoing operation and improvement of medical devices Quality Management System (QMS). This is a hands-on role for an experienced professional who is passionate about ensuring compliance and driving quality.

Key Areas of Responsibility:

• Quality Management System (QMS) Management: Maintain the QMS to ensure the efficiency of the document control process and compliance with company procedures and related standards.
• Compliance and Audits: Lead QMS compliance with both internal procedures and external regulations. You'll ensure adherence to 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR, along with other country-specific requirements. You'll also take the lead on audits and inspections by regulatory bodies and internal quality teams, preparing for them and ensuring documentation is ready.
• Corrective and Preventive Action (CAPA) and Non-Conformance (NC) Management: Lead CAPA investigations from issue identification through to root cause analysis, resolution, and effectiveness checks. You will also directly assist CAPA and NC owners to ensure their records are complete and comply with standards such as 21 CFR Part 820, ISO 13485, ISO 14971, and HIPAA.
• Data Analysis & Improvement: Analyze trends in non-conformances and CAPA data to identify systemic issues and contribute to continuous improvement initiatives. You'll also prepare monthly metrics, maintain logs, and send reminders for required activities.
• Product Lifecycle Support: Provide essential quality and regulatory support throughout the medical device lifecycle. This includes managing documentation for Software as a Medical Device (SaMD), supporting periodic software releases, and handling post-market activities.
• Cybersecurity and Data Privacy Compliance: Maintain a foundational understanding of an Information Security Management System (ISMS), and ensure the company's QMS and product documentation adhere to relevant security and privacy laws and regulations.
• Cross-functional Collaboration: Work closely with cross-functional teams to uphold a consistent and compliant approach to quality. You will draft regulated documentation and assist with quality improvement initiatives across the organization.

Essential skills, qualifications and experience:

Regulatory Knowledge: In-depth understanding of medical device regulations,

including 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR.

QMS Expertise: Proven, hands-on experience in managing and improving a QMS, with a

strong grasp of document control processes and how to maintain product-related quality

documentation.

Auditing: Experience leading audits and inspections by regulatory bodies. The ability to

manage deliverables, track corrective actions, and ensure timely closure is essential.

CAPA/NC Management: Direct experience leading CAPA investigations from root cause

analysis through to resolution and effectiveness checks. You must have the ability to

ensure documentation for CAPAs and NCs complies with various standards, including

HIPAA.

Data Analysis: Strong analytical skills to analyze trends in quality data and identify

systemic issues.

Communication: Excellent communication and collaboration skills to work effectively

with various teams and external parties.

Education: Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences).

Experience:

o Minimum of 3-5 years of experience in a Quality or Regulatory role within the

medical device industry.

o Prior experience with EU MDR is required.

o Demonstrated experience managing and drafting regulated documentation.

o Experience with pre-market and post-market activities for medical devices.

o Basic understanding of medical device production activities.

Desirable criteria:

Certifications: Professional certifications such as ISO 13485 and MDSAP Internal Auditor,

ASQ (American Society for Quality) are a plus.