RA, QA, EU MDR, US FDA & Medical Device Internship Roles
Job Description:
๐ ๐๐ถ๐ฟ๐ถ๐ป๐ด: RA, QA, EU MDR, US FDA & Medical Device Internship Roles
๐ ๐๐ผ๐ฐ๐ฎ๐๐ถ๐ผ๐ป: Ahmedabad, Gujarat
๐ผ ๐๐
๐ฝ๐ฒ๐ฟ๐ถ๐ฒ๐ป๐ฐ๐ฒ: 0โ4 Years
๐งพ ๐๐ผ๐ฏ ๐ง๐๐ฝ๐ฒ: Full-Time / Internship
๐ข ๐ช๐ผ๐ฟ๐ธ ๐ ๐ผ๐ฑ๐ฒ: On-site
๐ข ๐๐ผ๐บ๐ฝ๐ฎ๐ป๐: Maven
๐งพ ๐ฅ๐ผ๐น๐ฒ ๐ข๐๐ฒ๐ฟ๐๐ถ๐ฒ๐:
Maven is currently hiring for multiple Regulatory Affairs (RA), Quality Assurance (QA), EU MDR, US FDA, and Medical Device Internship roles at its Makarba, Ahmedabad office. These opportunities are ideal for freshers, entry-level professionals, and experienced candidates from Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, and related backgrounds who want to build a strong career in the medical device and regulatory industry.
Candidates with knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, FDA 21 CFR, 510(k) submissions, CAPA, QMS, and medical device documentation are encouraged to apply.
๐ฏ ๐๐๐ฎ๐ถ๐น๐ฎ๐ฏ๐น๐ฒ ๐ข๐ฝ๐ฒ๐ป๐ถ๐ป๐ด๐:
โ ๐๐ฟ. ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐
๐ฒ๐ฐ๐๐๐ถ๐๐ฒ โ ๐๐จ ๐ ๐๐ฅ 2017/745
โข Experience: Minimum 6 Months
โข Prepare and maintain EU MDR technical documentation
โข Work on clinical evaluation reports and risk management files
โข Conduct regulatory gap assessments and support audit readiness
โข Coordinate regulatory submissions with cross-functional teams
โ ๐ฆ๐ฟ. ๐ฅ๐ ๐๐
๐ฒ๐ฐ๐๐๐ถ๐๐ฒ
โข Experience: 1โ4 Years
โข Handle EU MDR technical documentation and FDA 510(k) activities
โข Perform regulatory gap assessments and audit support
โข Coordinate with product development and QA teams
โข Work on global medical device compliance requirements
โ ๐๐ฟ. ๐ฅ๐ฒ๐ด๐๐น๐ฎ๐๐ผ๐ฟ๐ ๐๐
๐ฒ๐ฐ๐๐๐ถ๐๐ฒ โ ๐จ๐ฆ ๐๐๐
โข Experience: Minimum 6 Months
โข Support FDA medical device submissions and technical documentation
โข Work on 510(k), De Novo, and FDA compliance activities
โข Coordinate with R&D and quality teams
โข Interpret FDA guidance documents and standards
โ ๐๐๐ป๐ถ๐ผ๐ฟ ๐ค๐ โ ๐๐ ๐ ๐๐
๐ฒ๐ฐ๐๐๐ถ๐๐ฒ
โข Experience: Minimum 6 Months
โข Support ISO 13485 Quality Management Systems
โข Maintain SOPs, CAPA records, and audit documentation
โข Assist in QMS implementation and compliance activities
โ ๐๐
๐ฒ๐ฐ๐๐๐ถ๐๐ฒ ๐๐๐๐ถ๐๐๐ฎ๐ป๐
โข Experience: 0โ1 Years
โข Manage meetings, communication, and reporting
โข Coordinate with stakeholders and internal teams
โข Track project timelines and follow-ups
โ ๐ฅ๐-๐ค๐ ๐๐ป๐๐ฒ๐ฟ๐ป โ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐๐ฒ๐๐ถ๐ฐ๐ฒ
โข Duration: 6 Months
โข Support ISO 13485 documentation and MDR/IVDR projects
โข Maintain QMS records and document trackers
โข Assist senior consultants in regulatory activities
๐ ๏ธ ๐๐ฒ๐ ๐ฆ๐ธ๐ถ๐น๐น๐:
โ Knowledge of EU MDR 2017/745 and FDA regulations
โ Understanding of ISO 13485, ISO 14971, QMS, and CAPA
โ Familiarity with FDA 21 CFR and 510(k) submissions
โ Strong documentation and analytical skills
โ Medical device regulatory and compliance understanding
โ Good communication and project coordination skills
๐ ๐ฅ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐ฑ ๐ค๐๐ฎ๐น๐ถ๐ณ๐ถ๐ฐ๐ฎ๐๐ถ๐ผ๐ป๐:
โ Bachelorโs or Masterโs degree in:
โข Life Sciences
โข Pharmacy
โข Biomedical Engineering
โข Biotechnology
โข Microbiology
โข Biochemistry
โข Regulatory Affairs
โข Quality Management
โข Related fields
๐ ๐ช๐ต๐ ๐๐ฝ๐ฝ๐น๐:
โ Excellent opportunity to build a career in Medical Device Regulatory Affairs
โ Hands-on exposure to EU MDR, FDA, ISO 13485, and risk management systems
โ Opportunity to work on global regulatory submissions and compliance projects
โ Strong learning environment for freshers and early-career professionals
โ Career growth in QA, RA, and Regulatory Consulting domains
โ ๏ธ ๐๐บ๐ฝ๐ผ๐ฟ๐๐ฎ๐ป๐ ๐ก๐ผ๐๐ฒ๐:
โ Selected candidates must sign a 2-year bond at the time of joining
โ Only shortlisted candidates will be contacted by the HR team
โ Candidates are advised not to call or WhatsApp unless contacted officially
โ Please do not send emails unless shortlisted
๐ฌ ๐๐ผ๐ถ๐ป ๐ช๐ต๐ฎ๐๐๐๐ฝ๐ฝ ๐๐ฟ๐ผ๐๐ฝ:
๐Join now