Sundas Asif
Post-Market Surveillance | Regulatory Affairs
Lowell
Summary
Detail-oriented Regulatory Affairs professional with hands-on experience in post-market surveillance and quality assurance within regulated medical device environments. Proven ability to manage regulatory reporting, ensure global compliance, and collaborate cross-functionally to support product safety and operational excellence. MBA in Finance, bringing strong analytical, business, and risk-management insight to regulatory strategy.
Overview
2026
2026
years of professional experience
Work History
Regulatory Affairs Coordinator
ZOLL Medical Corporation
11.2023 - 01.2026
- Lead Post-Market Surveillance (PMS) activities to ensure ongoing safety and regulatory compliance of medical devices across global markets.
- Monitor, analyze, and document post-market data, ensuring timely and accurate regulatory reporting.
- Stay current with evolving international medical device regulations and standards (ISO, MDR/IVDR).
- Collaborate with Quality, Engineering, and Clinical teams to support regulatory submissions and documentation.
- Contribute to continuous improvement initiatives to strengthen compliance processes and operational efficiency.
Quality Assurance Analyst
Remit Choice Limited
09.2022 - 10.2023
- Developed and maintained internal quality benchmarks for support and call-center operations.
- Evaluated customer interactions for compliance with internal standards and financial regulations.
- Identified process gaps and implemented continuous improvement strategies to enhance service quality.
- Produced performance and compliance reports for management review.
Clean Room Operator
Cirtec Medical
2022 - 2023
- Performed precision assembly, inspection, and testing of medical devices in cleanroom environments.
- Maintained strict adherence to Quality Management Systems (QMS) and safety protocols.
- Packaged and documented equipment according to medical-grade standards, ensuring product integrity and traceability
Customer Support Officer
Remit Choice Limited (Project Under KQ Consultants
06.2022 - 09.2022
- Delivered high-quality customer service and technical support.
- Trained and mentored junior staff on service protocols and CRM systems.
- Supported onboarding and knowledge-sharing initiatives.
Financial Services Manager
IGI Life Insurance
03.2021 - 03.2022
- Generated and analyzed financial reports to guide business strategy and investment decisions.
- Provided advisory support on revenue growth and profitability.
- Ensured compliance with anti-money laundering (AML) and financial regulations.
- Assisted leadership with budgeting, forecasting, and risk assessment.
Education
MBA - Master of Business Administration (MBA) — Finance
Shah Abdul Latif University
09-2023
Skills
Stakeholder communication
Auditing procedures
Environmental regulations
Medical device regulations
Regulatory strategy development
GxP guidelines
Pharmaceutical industry
Biotechnology regulations
Change control
Clinical trials oversight
Post-Market Surveillance (PMS)
Regulatory Compliance & Reporting
FDA regulations
Medical Device Regulations
Calibration & Product Quality
Financial Reporting & Analysis
Operational Efficiency
Risk Management (AML
Performance Reporting
Cross-Functional Collaboration
Strategic Business Support
Complex Problem Solving
Strong Work Ethic & Accountability
Timeline
Regulatory Affairs Coordinator
ZOLL Medical Corporation
11.2023 - 01.2026
Quality Assurance Analyst
Remit Choice Limited
09.2022 - 10.2023
Customer Support Officer
Remit Choice Limited (Project Under KQ Consultants
06.2022 - 09.2022
Financial Services Manager
IGI Life Insurance
03.2021 - 03.2022
Clean Room Operator
Cirtec Medical
2022 - 2023
MBA - Master of Business Administration (MBA) — Finance
Shah Abdul Latif University