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Experienced Regulatory Executive
Maven Profcon Services
posted 3+ weeks ago
Job Role Insights
Key skills for the job
Job Description
- 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:
- Bachelors or Masters degree in life sciences, biomedical engineering, pharmacy, or a related field.
- Minimum 1-2 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.
Employment Type: Full Time, Permanent
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What people at Maven Profcon Services are saying
Regulatory Executive salary at Maven Profcon Services
reported by
2
employees
with 1
years exp.
₹2.9
L/yr - ₹3.7
L/yr
20%
less
than the average Regulatory Executive Salary in India
View more details
What Maven Profcon Services employees are saying about work life
based on 5 employees
Alternate Saturday off
Within country
Day Shift
Maven Profcon Services Benefits
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