Regulatory Affairs Executive

6 days ago

Najafgarh, Delhi, India Madhu Instruments Pvt Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

We are seeking an experienced Executive/Sr. Executive in Quality Assurance with 2-5 years of experience in medical device manufacturing. This role requires comprehensive knowledge of regulatory requirements and quality standards to support certification audits, manage technical and quality documentation, and ensure compliance with Indian Medical Device Rule 2017, EU MDR 2017/745, and ISO 13485:2016 standards.

1.
Device Master File Compliance

o Draft the Device Master File to align with Indian Medical Device Rule 2017 requirements, ensuring full compliance for regulatory submissions and audits.

2.Clinical Data Collection and Compilation

o Collect and compile data related to device safety and performance from scientific journals and databases, including EMBASE, PubMed, and Cochrane, to support regulatory submissions and product evaluations.

3.Technical Documentation and Regulatory Compliance

o Assist in drafting technical documents, including Biological Evaluations, Risk Management, and Usability Reports, in compliance with EUMDR 2017/745 regulations.

o Prepare and manage technical files for certification audits to meet EUMDR 2017/745 standards, ensuring that all documentation is thorough and accurate.

4.
Quality Management System (QMS) Compliance

o Ensure thorough understanding and implementation of QMS standards as per ISO 13485:2016 and Annexure IX of EUMDR 2017/745.

o Maintain and update all QMS documentation, including manuals, procedures, and policies, to ensure ongoing compliance with quality standards.

5.
Quality Documentation Management

o Create, update, and manage company quality documentation, ensuring that manuals, procedures, and records are maintained accurately.

o Monitor and enforce consistent implementation of quality management systems across the organization.

o Address any non-conformance reports promptly and efficiently, working toward continuous improvement.

6.
Customer Complaint and Incident Management

o Handle customer complaints through root cause analysis and responsive solutions, addressing vigilance reporting and managing product recalls as necessary to maintain product integrity and customer satisfaction.

Qualifications and Skills:

·
Education:
Bachelor's degree in a relevant scientific or engineering field, preferably with a focus on medical devices.

·
Experience:
2-5years in QA for medical device manufacturing, with in-depth knowledge of relevant regulations and standards.

·
Technical Skills:

o Proficiency in regulatory requirements (Indian Medical Device Rule 2017, EUMDR 2017/745, ISO 13485:2016).

o Expertise in data sourcing from EMBASE, PubMed, and Cochrane, with strong data compilation skills for clinical evaluations.

·
Soft Skills:

o Strong written and verbal communication skills.

o Excellent organizational skills and attention to detail.

Benefits:
Competitive salary, professional growth opportunities, and a collaborative environment dedicated to excellence in quality assurance & Regulatory Affairs

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