Regulatory Affairs Officer

Company : Medical Device Company, having H.Q. at Europe & Corporate office in Ahmedabad

Position : Regulatoy Affairs Officer (Medical Device)

Location : Ahmedabad

Industry : Medical Device (MNC)

Key Responsibilities:

MAIN DUTIES/RESPONSIBILITIES

REGULATORY TASKS

1. Gather and consolidate regulatory data related to medical device registrations from internal and external sources.

2. Enter and maintain data in the companys product data management tool, Portal of Ministry of Health, and EUDRAMED ensuring completeness, accuracy and compliance with MDR.

3. Review of technical documents of medical devices in line with CE/MDR requirements.

4. Verification of CE, ISO and other certificates for its authenticity with certificate issuing body.

QA TASKS

5. Perform desktop evaluations of manufacturers.

6. Collect and assess documents needed for product approval included but not limited to product questionnaire, product specifications, release criteria, clinical evaluation, PMS, aging studies.

7. Undertake the necessary discussions with the manufacturer with reference to product range, ISO

13485/MDR compliance and product file level.

8. Develop and document Standard Operating Procedures (SOPs) and work instructions to support long-term data integrity and consistency.

9. Review and approval of product documentation in share point.

10. Assist in review of medical device with reference to layout approval and COA review.

OTHER SUPPORTING ACTIVITIES

11. Assist in continuous improvement of quality management system to ensure better harmonization of pre-qualification status, regulatory activities and procurement activities.

12. Coordinate with QA claims, deviations, root cause, product review and retesting for medical devices.

13. Coordinate with purchase and sales in any issue related to products, client/manufacturer on quotations.

14. Help in training and knowledge sharing to other QD team members with current updates

15. Official travel abroad as and when required.

Requirements:

• B.Pharm / M.Pharm / B.E. (Biomedical)
• Work experience: 3-5 years of experience in medical devices industry, especially in RA, QA/QC or Documentation. Preferably experience from an international company.
• Competences:

- Hands on experience with class I and II medical devices

- Knowledge of ISO 13485, EU MDR, CE and other regulatory/ISO standards for medical devices.

- Should be able to review regulatory and technical documents such as FSC (Free sales certificate), CE, ISO certificates

- Ability to use current job-related computer software and databases with proficiency in Microsoft Office package, in particular Word, Excel and PowerPoint, is required. Languages: Proficiency in English Understanding of Italian language is advantage

Contact

Rina Arun