Maven is hiring for the position of Junior Regulatory Executive – EU MDR/IVDR at its Makarba, Ahmedabad location. This opportunity is suitable for candidates with a bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related discipline who want to build a career in Medical Device Regulatory Affairs.
Candidates should have at least 6 months of internship experience in Medical Device/IVD Regulatory Affairs, particularly involving EU MDR 2017/745 and EU IVDR 2017/746.
The Junior Regulatory Executive will support regulatory documentation, technical files, risk management activities, clinical/performance evaluation documentation, Notified Body submissions, and US FDA 510(k) dossier preparation.
Job Overview
Company: Maven
Position: Junior Regulatory Executive – EU MDR/IVDR
Department: Medical Device/IVD Regulatory Affairs
Location: Makarba, Ahmedabad, Gujarat
Employment Type: Full-Time
Experience Required: Minimum 6 months internship experience in Medical Device/IVD Regulatory Affairs
Regulations: EU MDR 2017/745 and EU IVDR 2017/746
Standards: ISO 13485 and ISO 14971
Application Mode: Online
Key Responsibilities
As a Junior Regulatory Executive at Maven, the selected candidate will support Medical Device and IVD regulatory activities under appropriate supervision. Key responsibilities include:
- Assist with preparation and maintenance of regulatory documentation in accordance with EU MDR 2017/745 and EU IVDR 2017/746.
- Support the preparation, review, organization, and maintenance of technical documentation.
- Assist with risk management files and related regulatory records.
- Support preparation of Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER).
- Assist with regulatory gap assessments and implementation of applicable regulatory requirements.
- Coordinate with cross-functional teams to obtain data and documentation required for regulatory deliverables.
- Support preparation of Notified Body submissions and responses to regulatory queries.
- Assist with compilation of US FDA 510(k) dossiers, including predicate device analysis.
- Monitor relevant regulatory changes and contribute to maintaining the organization’s regulatory knowledge base.
Qualifications and Eligibility
Candidates interested in this Maven Junior Regulatory Executive job in Ahmedabad should meet the following requirements:
Education: Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
Candidates from relevant backgrounds such as B.Pharm, Biomedical Engineering, Biotechnology, Microbiology, Biochemistry, and other applicable Life Science disciplines may be suitable, subject to Maven’s screening criteria.
Experience: Minimum 6 months of internship experience in Medical Device/IVD Regulatory Affairs, preferably involving EU MDR/IVDR.
Applicants should also have:
- Basic understanding of EU MDR 2017/745
- Basic understanding of EU IVDR 2017/746
- Knowledge of ISO 13485
- Knowledge of ISO 14971
- Familiarity with Medical Device/IVD regulatory documentation
- Good documentation and organizational skills
- Strong attention to detail
- Effective communication skills
- Ability to collaborate within cross-functional teams
Key Regulatory Skills
This role can provide practical exposure to several important areas of Medical Device Regulatory Affairs, including EU MDR, EU IVDR, CE Marking, technical documentation, risk management, clinical evaluation, performance evaluation, Notified Body submissions, ISO 13485, ISO 14971, and US FDA 510(k) documentation.
Candidates seeking to establish a career in Medical Device Regulatory Affairs jobs in Ahmedabad may find this position particularly relevant because it combines European medical device and IVD regulations with exposure to US regulatory submissions.
Why Consider This Opportunity?
The Maven Junior Regulatory Executive position offers early-career regulatory professionals an opportunity to gain hands-on exposure to the regulatory lifecycle of Medical Devices and IVDs.
Potential professional-development benefits include experience with:
- EU MDR 2017/745 and EU IVDR 2017/746
- Medical Device and IVD technical documentation
- CE Marking regulatory requirements
- Risk management documentation
- Clinical and performance evaluation
- Notified Body submission support
- US FDA 510(k) dossier preparation
- Cross-functional regulatory coordination
Specific compensation, employee benefits, and other employment terms have not been stated in the recruitment information and should be confirmed directly with Maven during the selection process.