If you’re looking to build a career in medical device regulatory affairs or quality assurance, this opportunity at Maven Profcon Services LLP could be a strong entry point. The company is actively hiring for Junior Regulatory Executive (US FDA & EU MDR) and Junior QA Executive roles in Ahmedabad.
This hiring drive is ideal for candidates with 6+ months experience in regulatory compliance, ISO standards, and medical device documentation, especially those aiming to work on global approvals like US FDA 510(k), EU MDR 2017/745, and CE certification.
๐ Job Overview
- Company: Maven Profcon Services LLP
- Location: Ahmedabad, Gujarat (On-site)
- Job Type: Full-time
- Experience Required: Minimum 6 months
- Industry: Medical Device Regulatory Affairs / Quality Assurance
๐งช Key Responsibilities
Regulatory Roles (US FDA / EU MDR)
- Prepare and review regulatory documentation including:
- Clinical Evaluation Reports (CER)
- Risk Management Files (RMF)
- Post-Market Surveillance (PMS)
- Assist in US FDA 510(k) submissions and predicate device analysis
- Support EU MDR 2017/745 compliance and CE certification processes
- Maintain documentation for UKCA and global regulatory submissions
- Track updates in international regulatory guidelines
QA Role (AMC Executive)
- Ensure compliance with ISO 13485 Quality Management System (QMS)
- Handle document control and audit preparation
- Support risk management processes
- Assist in internal and external audits
๐ Qualifications & Skills
- Bachelorโs degree in:
- Life Sciences
- Biomedical Engineering
- Regulatory Affairs
- Related discipline
- Knowledge of:
- US FDA regulations (510k)
- EU MDR 2017/745
- ISO 13485 & MDSAP
- Strong skills in:
- Regulatory writing & documentation
- Analytical research
- Communication & organization
โ Freshers with relevant training in medical device regulatory affairs may also apply.
๐ผ Salary & Benefits
- Estimated Salary: โน3.5 LPA โ โน6 LPA (based on experience)
- Hands-on exposure to global regulatory frameworks
- Opportunity to work with international medical device clients
- Career growth in regulatory consulting and compliance
๐ Why Join Maven Profcon Services?
Maven Profcon Services LLP is a recognized regulatory consulting firm supporting over 300+ global organizations, particularly in orthopedic and medical device sectors. The company specializes in helping manufacturers achieve market access across US, EU, and UK regions, making it an excellent platform for early-career professionals.