Medical device regulatory and quality assurance professionals looking for career opportunities in Gujarat now have multiple openings available at Maven. The company is currently hiring for several Regulatory Affairs (RA), Quality Assurance (QA), EU MDR, US FDA, and internship positions at its Makarba, Ahmedabad office.
These openings are suitable for freshers, entry-level candidates, and experienced professionals from Life Sciences, Biomedical Engineering, Pharmacy, and related backgrounds who want to build a career in the medical device industry.
Candidates with knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, FDA 21 CFR, 510(k) submissions, QMS, CAPA, and medical device documentation are encouraged to apply.
Available Openings at Maven
1. Jr. Regulatory Executive – EU MDR 2017/745
Location: Makarba, Ahmedabad, Gujarat
Experience: Minimum 6 months
Employment Type: Full Time
Key Responsibilities
- Prepare and maintain EU MDR technical documentation
- Work on clinical evaluation reports and risk management files
- Conduct gap assessments against EU MDR 2017/745 requirements
- Coordinate with cross-functional teams for regulatory submissions
- Support Notified Body submissions and audit readiness
- Interpret global regulatory requirements for internal teams
Required Skills
- Knowledge of EU MDR 2017/745
- Experience with ISO 14971 and MEDDEV guidance
- Strong documentation and project management skills
- Medical device regulatory affairs experience preferred
2. Sr. RA Executive
Location: Makarba, Ahmedabad, Gujarat
Experience: 1–4 Years
Employment Type: Full Time
Key Responsibilities
- Prepare EU MDR documentation and technical files
- Support FDA 510(k) submission activities
- Perform regulatory gap assessments
- Coordinate with product development and QA teams
- Handle audit readiness and Notified Body responses
Required Skills
- Strong knowledge of EU MDR 2017/745
- Familiarity with FDA 21 CFR Part 820
- Understanding of 510(k) submission process
- Experience in medical device regulatory affairs
3. Jr. Regulatory Executive – US FDA
Location: Makarba, Ahmedabad, Gujarat
Experience: Minimum 6 months
Employment Type: Full Time
Key Responsibilities
- Support US FDA medical device regulatory submissions
- Prepare 510(k), De Novo, and technical documentation
- Conduct FDA regulatory gap assessments
- Coordinate with R&D and quality teams
- Interpret FDA guidance documents and standards
Required Skills
- Knowledge of FDA medical device regulations
- Understanding of 21 CFR Parts 800–1299
- Familiarity with ISO 14971 and QSR requirements
- Strong documentation skills
4. Junior QA – AMC Executive
Location: Makarba, Ahmedabad, Gujarat
Experience: Minimum 6 months
Employment Type: Full Time
Key Responsibilities
- Support ISO 13485 Quality Management Systems
- Maintain SOPs, CAPA records, and training documentation
- Assist in audit preparation and QMS implementation
- Coordinate with internal teams and clients
Required Skills
- Knowledge of ISO 13485
- Understanding of CAPA, internal audits, and document control
- Good analytical and communication skills
5. Executive Assistant
Location: Makarba, Ahmedabad, Gujarat
Experience: 0–1 Years
Employment Type: Full Time
Key Responsibilities
- Manage calendars, meetings, and official communication
- Prepare reports, presentations, and meeting minutes
- Coordinate with stakeholders and internal teams
- Track project deadlines and follow-ups
Required Skills
- Excellent communication and organizational skills
- MS Office proficiency
- Ability to multitask and manage deadlines
6. RA-QA Intern – Medical Device
Location: Makarba, Ahmedabad, Gujarat
Contract Duration: 6 Months
Responsibilities
- Support ISO 13485 documentation
- Assist MDR and IVDR projects
- Maintain QMS records and document trackers
- Support senior consultants in regulatory activities
Eligibility
- Pursuing Master’s in Biomedical Engineering / Regulatory Affairs / QA
- Interest in Medical Device Regulatory Affairs
- Good documentation and MS Office skills
Why Candidates Should Apply
These Maven job openings provide excellent opportunities for candidates interested in:
- Medical Device Regulatory Affairs
- EU MDR 2017/745 Compliance
- FDA 510(k) Regulatory Submissions
- Quality Assurance and ISO 13485
- Medical Device Documentation
- Regulatory Consulting Careers
Freshers and early-career professionals can gain hands-on exposure to global regulatory frameworks including EU MDR, FDA, ISO 13485, and risk management systems.
Important Notes
- Selected candidates must sign a 2-year bond at the time of joining.
- Only shortlisted candidates will be contacted by the HR team.
- Candidates are advised not to call or WhatsApp unless contacted officially.
How to Apply
Only shortlisted candidates will be contacted by our HR team. Kindly do not call or WhatsApp unless you are contacted first. Please Dont mail Or Contact Only Shortlisted Candidates will Recieve the calls