Regulatory Affairs Executive

5 days ago

Mysore, India S3V vascular Technologies Full time

Prepare, review, file, and support premarket documents for Indian and global
registrations for assigned medical device projects.
- Collaborate with intra and inter department personnel and support marketing
authorizations for assigned projects.
- Represent Regulatory Affairs as team member of product development projects from
Concept through Commercialization.
- Review pre-clinical and clinical protocols and associated reports to be used in
submissions for assigned projects.
- Develop Regulatory Strategies for new or modified products for assigned projects.
- Monitor and provide information pertaining to impact of changes in the regulatory
environment.
- Communicate with regulatory agencies and/or notify bodies on administrative and routine
matters.
- Document, consolidate, and maintain oral and written communication with health
authorities
- Prepare internal documents for modifications to devices, when appropriate.
- Participate in health agency inspections & notified body audits as necessary.
- Author and/or review regulatory procedures and update as necessary.
- Assist in development/maintenance of regulatory files, records, and reporting systems of
systematic retrieval of information.
- Review promotional material, advertising, and labeling to ensure regulatory compliance
on assigned projects.
- Collaborate and partner with NPD, Purchase, QA, QC, Clinical Affairs, Marketing and
Operations department.

Experience and skills:
0-2 years experiences for RA role in medical device.
Good understanding of Indian Medical Devices Rules,2017. ISO 13485. ISO 14971. NOC Dual
Use Guidelines. Drugs and Cosmetic Act and Rules. NPPA.
Good understanding of medical device related regulations and policies issued by India, US FDA,
ASTM, ISO and EU, and ability to interpret international regulatory requirements.
Excellent written, organizational, and communication skills is required, and have a flexible and
team oriented attitude.

**Job Types**: Full-time, Regular / Permanent

Schedule:

- Day shift

Ability to commute/relocate:

- Mysore, Karnataka: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**

+91-XXXXXXXXXX

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