Senior Regulatory

1 week ago

Ahmedabad, Gujarat, India Maven Profcon Services LLP Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Key Responsibilities:

  • Develop, review, and maintain regulatory documentation in accordance with EU MDR 2017/745, including technical documentation, risk management files, and clinical evaluation reports.
  • Conduct gap assessments against EU MDR requirements to identify areas for improvement and support implementation strategies.
  • Coordinate with cross-functional teams to gather data and ensure alignment of regulatory submissions with product design and development processes.
  • Stay updated on relevant regulatory testing requirements and ensure compliance with applicable standards.
  • Support the preparation of Notified Body submissions, responses to queries, and audit readiness.
  • Assist in the compilation and submission of US FDA 510(k) dossiers, including predicate device analysis and regulatory strategy.
  • Interpret global regulatory requirements and translate them into clear guidance and actionable plans for internal and client teams.

Qualifications & Skills:

  • Bachelor's or Master's degree in life sciences, biomedical engineering, pharmacy, or a related field.
  • Minimum 1-4 years of hands-on experience in regulatory affairs within the medical device industry.
  • Demonstrated expertise in EU MDR 2017/745, with experience preparing clinical, risk, and performance documentation.
  • Strong understanding of ISO 14971 and MEDDEV guidance.
  • Familiarity with FDA 21 CFR Part 820 and 510(k) submission process is a plus.
  • Excellent communication, documentation, and project management skills.
  • Ability to work independently, prioritise tasks, and manage deadlines across multiple projects.

Note:
 Only shortlisted candidates will be contacted.

Job Location
: Makarba, Ahmedabad, Gujarat

Job type:
In-office, no WFH

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