Regulatory Affairs Executive

1 week ago

Bengaluru, India Indian Institute of Science, Bangalore Full time

**Responsibilities**:

- Work closely with Engineering team through product development process and design activities
- Author/participate in the design validation and process validations, IQ, OQ, PQ.
- Prepare, review risk management files and support risk management activities including hazard analysis and FMEA.
- Identify relevant guidance documents, international standards, or consensus documents and provide interpretive assistance.
- Interpret domestic or international laws, guidelines, standards, regulatory rules, or rule changes and ensure they are communicated through the company.
- Provide technical review of reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Author or revise Standard Operating Procedure (SOPs) to maintain the adequate quality management system of the organization.
- Maintain current knowledge base of existing and emerging regulations, standards or guidance documentations including the Indian Medical Device Rules, and all other standards/regulations within the applicable scope.
- Review or approve product labelling, specification sheets, or test methods for compliance with applicable regulations and policies.
- Administer CAPA Program. Perform CAPA investigations, implement corrective actions and perform effectiveness checks.
- Interface with supplier base to resolve quality and compliance issues.
- Coordinate and participate in internal and external audits.
- Coordinate, investigate, analyse product complaint and safety issues, and make recommendations regarding their reportability and resolution.
- Support and improve the company quality systems by creating a quality culture and provide on-going education on compliance activities.
- Contribute towards establishment of departmental and corporate goals and objectives.
- Any other duties as requested by his/her reporting head from time to time.

**Requirements**:

- 3 to 5 years of Class B (Class II) or above medical device quality and regulatory experience is required.
- Master’s Degree in a scientific discipline. Regulatory Affairs specialization is an added advantage.
- Excellent analytical and critical thinking skills
- Demonstrated knowledge participating in design control process of medical devices.
- Knowledge of IEC 60601 suite of standards is required. Knowledge with requirements for SaMD and/or embedded software regulations is highly preferred.
- Able to quickly learn third-party test requirements such as IEC product testing, biocompatibility testing, sterilization.
- Strong understanding of Indian, EU and FDA regulatory process. Prior experience with regulatory submissions to regulatory authorities is preferred.
- Demonstrated experience in carrying out risk management activities per ISO 14971. Experience with risk management for software is a plus.
- ISO 13485 internal/lead auditor certification is preferred. Experience in performing audits will be added advantage.
- Strong verbal and written communication skills in English, including a proven ability to translate technical documentation into effective quality documentation. Good communication skills in Hindi and Kannada are a plus.
- Able to work independently with mínimal instructions.
- Capable to multitasking and rapidly adapting to changing priorities.

**Job Types**: Full-time, Contractual / Temporary
Contract length: 24 months

**Salary**: Up to ₹600,000.00 per year

**Benefits**:

- Flexible schedule
- Health insurance
- Paid sick time

Schedule:

- Day shift
- Monday to Friday
- Morning shift
- Weekend availability

Supplemental pay types:

- Performance bonus
- Shift allowance

COVID-19 considerations:
Yes, all COVID precautions are taken.

Ability to commute/relocate:

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

Application Question(s):
**Education**:

- Bachelor's (required)

**Experience**:

- Medical Device Regulatory Affairs: 2 years (required)

Work Location: In person

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