Regulatory Affairs Executive

2 weeks ago

Jigani Bengaluru Karnataka, India ASTER MEDISPRO PVT LTD Full time

Provide responses to regulatory agencies regarding product information or issues.
- Train RA Assistant and staffs in regulatory policies or procedures. Coordinate internal discoveries and depositions with legal department staff.
- Develop and maintain standard operating procedures or local working practices.
- Establish regulatory priorities or budgets and allocate resources and workloads. Maintain and keep up to date on current knowledge of relevant regulations, including proposed and final rules.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Participate in the development or implementation of clinical trial protocols.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- Preparation of technical files for all the products as per the medical device regulations and facing the audit relating CE with appropriate notified bodies.
- Conformity of the product device to the Medical Device Regulation and Quality Management System
- Conformity of the Technical Documentation and EU Declaration of Conformity
- Compliance with Post-Market Surveillance (PMS) following Article 10(10)
- Compliance with the Vigilance Reporting obligations (Article 87 to 91)
- For Investigation devices issuance of a signed statement (Annex XV Chapter II Section 4.1)
- Establish, implement & maintain the quality system.
- Organize & report the performance of the quality management system in management review.
- Responsible for Plan, schedule and co-ordinate internal quality audits.
- Communicate with external bodies on matters relating to the quality management system.
- Responsible for issue of Quality System documents.
- Co-ordinate with internal auditors for conduct of IQA.
- Responsible to conduct meetings on non-conformance arrived during IQA & Regulatory audits.
- Responsible for review and updating of mandatory procedures as and when there is change in any system Standard, Schedule, Medical Device Directive, Harmonized Standards, Internal audit, continual improvement, certification audit.
- Review and update Procedure and Formats of the process.
- Providing Training to all the Process In charges about the updates.
- Periodic review and update in regulatory documents.
- Carryout Internal Quality Audit.
- Responsible for preparation of process work instructions.

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

**Salary**: ₹10,000.00 - ₹100,000.00 per month

**Benefits**:

- Leave encashment
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

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

**Education**:

- Master's (preferred)

**Experience**:

- total work: 5 years (preferred)

Work Location: In person

**Speak with the employer**
+91 8951202820

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