Regulatory Affairs Associate

3 weeks ago

CV Raman Nagar Bengaluru Karnataka, India Indian Institute of Science, Bangalore Full time

**About Company**:
Foundation of Science, Innovation and Development (FSID) and Department of Design and Manufacturing (DM) at Indian Institute of Science (IISc), Bengaluru support the research, development, and commercialization of affordable and accessible medical devices for indigenous and resource constrained populations. The research team from IISc is currently working to commercialize two innovative Class C medical devices: “Insuflo”: This will be India’s first indigenous insulin infusion pump and “Lifebox”: A novel device for prolonged preservation and transportation of human organs for transplantation.

**Address: Design Innovation Centre (DeSIC), Department of Design and Manufacturing, Indian Institute of Science, Bengaluru**

**About Position**:
Position Title : Regulatory Affairs Associate

Reports To : Project Leader (CEO)

**Salary**: At par with industry standards, (negotiable based on qualifications and experience)

Tenure : Minimum 1 year

Benefits : Medical coverage, performance bonus, paid leave

Location : Full time, on-site role

Working Hours : Monday to Friday, Flexible working hours

Probation : Three months from date of joining, full pay in probation period.

Joining Date : Available to join in less than 30 days

**Responsibilities**:

- **Work closely with consultants to develop a quality management system as per requirements of ISO 13485 standard.**:

- Provide technical review of reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- **Work closely with Engineering team through product development process and design activities.**:

- 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.**:

- Support clinical affairs by drafting, review, amendments and submission of protocols, clinical evaluation reports etc.
- **Author or revise Standard Operating Procedure (SOPs) to maintain the adequate quality management system of the organization.**:

- Prepare, review risk management files and support risk management activities including hazard analysis and FMEA.
- 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.
- 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.

**Qualifications and Experience**:

- **A minimum of 3 years of Class B (Class II) or above medical device quality and regulatory experience is required.**:

- Degree in a science, engineering, or pharmacy. Master’s degree is highly preferred. Regulatory Affairs coursework is an added advantage.
- Excellent analytical and critical thinking skills
- Prior experience in small organizations or startups and working with fast paced and dynamic environments. New Product Development (NPD) exposure is highly recommended.
- **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

**Benefits**:

- Flexible schedule
- Health insurance
- Leave encashment
- Life insurance
- Paid sick time

Schedule:

- Day shift
- Morning shift

Supplemental pay types:

- Yearly bonus

**Experience**:

- total work: 3 years (preferred)

**Location**:

- CV Raman Nagar, Bengaluru, Karnataka (preferred)

Work Location: In person

**Speak with the employer**

+91 9606587066

Expected Start Date: 15/04/2024

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