Regulatory Affairs- Medical Device Development

3 weeks ago

Navi Mumbai, Maharashtra, India IF MedTech Pvt Ltd Full time

At IF MedTech, we are dedicated to revolutionizing healthcare through cutting-edge medical device design, development, and pilot manufacturing. Our global team collaborates with experts across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives. Join us in our mission to drive innovation and make a global impact in the medical technology sector.

Responsibilities

  • Develop, review, and maintain Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) in line with EU MDR, MEDDEV 2.7/1 Rev. 4, and relevant MDCG guidance documents.
  • Conduct systematic literature reviews and clinical data analysis
  • Update CERs based on findings from Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF) studies, and risk management files.
  • Collaborate with clinical, design, and risk management teams to gather relevant inputs.
  • Prepare and maintain PMS Plans, PMS Reports, and PMCF Plans/Reports.
  • Develop and update Periodic Safety Update Reports (PSURs) and Summaries of Safety and Clinical Performance (SSCPs).
  • Analyze complaint data, adverse events, and other real-world evidence to detect trends or emerging risks.
  • Coordinate vigilance reporting and Field Safety Corrective Actions (FSCAs).
  • Review and verify device labels and packaging artwork for compliance with EU MDR, FDA, ISO 15223-1, ISO 20417, and other applicable standards.
  • Ensure correct inclusion of symbols, warnings, contraindications, and UDI information.
  • Update and maintain Instructions for Use (IFUs) in alignment with CER, risk files, and usability findings.
  • Support labelling translations and ensure adherence to country-specific labelling requirements.
  • Lead or support CAPA initiation, investigation, root cause analysis, and closure for product quality or regulatory compliance issues.
  • Work with Quality Assurance and Engineering teams to define and verify corrective/preventive actions.
  • Track CAPA timelines and ensure documentation is in accordance with ISO 13485 requirements.
  • Participate in continuous improvement initiatives from audit findings, PMS insights, and internal reviews.

Qualifications

  • Bachelor's or Master's degree in Biomedical Engineering, Life Sciences, Pharmacy, or related discipline.
  • 3–6 years in Regulatory Affairs within the medical device industry.
  • Proven track record in CERs, PMS, device labelling, and CAPA management.
  • Strong knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, MEDDEV 2.7/1 Rev. 4, and related regulations/standards.
  • Proficiency in literature search tools (PubMed, Embase).
  • Strong technical writing and documentation skills for regulatory submissions.
  • Excellent analytical and problem-solving abilities.
  • Strong interpersonal and cross-functional collaboration skills.
  • Ability to manage multiple priorities under regulatory timelines.

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