What are the responsibilities and job description for the POST MARKET SURVILLANCE / Regulatory Specialists position at TekOne IT Services Pvt. Ltd.?
Role: Post Market Surveillance / Regulatory Specialist
Key Responsibilities
Key Responsibilities
- Post Market Surveillance:
- Collect, analyze, and report post-market data for medical devices, including complaints, adverse events, and device performance.
- Maintain and update Post Market Surveillance (PMS) plans and reports according to regulatory requirements (EU MDR, FDA).
- Investigate product complaints and conduct risk assessments for field actions such as recalls or safety notices.
- Identify trends in post-market data to ensure timely corrective and preventive actions (CAPA).
- Regulatory Compliance:
- Ensure compliance with FDA (21 CFR Part 820), EU MDR (Regulation (EU) 2017/745), ISO 13485, and other applicable regulatory requirements.
- Support the development, submission, and maintenance of regulatory filings such as 510(k), PMA, CE marking, and Technical Files.
- Prepare and submit Medical Device Reports (MDR) and Vigilance Reports (EU) within regulatory timelines.
- Work closely with cross-functional teams to ensure compliance with global post-market surveillance regulations.
- Complaint Handling and Reporting:
- Manage the complaint handling process, including investigation, root cause analysis, and customer follow-up.
- Collaborate with engineering, quality, and manufacturing teams to resolve product issues identified through post-market data.
- Prepare and review regulatory submissions, ensuring compliance with regulatory standards.
- Risk Management:
- Conduct post-market risk assessments and coordinate safety reviews.
- Ensure documentation and reporting of safety and performance data in accordance with risk management processes (ISO 14971).
- Continuous Improvement:
- Participate in process improvements related to post-market surveillance, regulatory compliance, and complaint handling systems.
- Support audits (internal and external) and regulatory inspections.
- Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
- 2 years of experience in Post Market Surveillance, Regulatory Affairs, or Quality Assurance in the medical device industry.
- Solid understanding of regulatory requirements, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and ISO 14971.
- Experience with post-market surveillance activities, complaint handling, and reporting of adverse events for medical devices.
- Familiarity with regulatory submission processes (510(k), PMA, CE marking, etc.).
- Strong analytical skills and ability to interpret and apply regulatory guidance.
- Excellent communication skills, both written and verbal.
- Strong organizational and project management skills.
