Genuine Biosystem Pvt. Ltd. specializes in the manufacturing of high-quality in-vitro diagnostic devices. With a commitment to excellence and compliance, we strive to meet global healthcare standards and provide superior diagnostic solutions.
Job Role: Senior QARA Executive
Key Responsibilities:
- Regulatory Compliance:
- Directly interact with regulatory agencies, including visits to State Licensing Authorities, Central Licensing Authorities, and other government offices as required.
- Prepare, review, and file premarket documents for global registrations of assigned projects.
- Documentation and Audits:
- Prepare document packages for international regulatory submissions, internal audits, and inspections.
- Conduct internal audits as per ISO 13485, MDSAP, USFDA, EU IVDR, and IMDR requirements.
- Strategic Development:
- Develop regulatory strategies for new or modified products and monitor regulatory changes in the environment.
- Author and update regulatory and quality system procedures to maintain compliance.
- Change Management:
- Review change control documents and assess their regulatory impact through formal assessments.
- Assist in maintaining regulatory files, records, and reporting systems for systematic retrieval of information.
- Gap Analysis and Validation:
- Perform gap analysis, remediation, and submission of documents as per EU IVDR 2017/746.
- Prepare manufacturing, testing, and import license documents in compliance with IMDR 2017.
- Oversee process, product, and equipment validation as per IQ, OQ, and PQ protocols.
- Team Coordination:
- Collaborate and coordinate with QA and RA team members to ensure seamless workflow.
Candidate Qualifications
- Experience: A minimum of 3+ years in the medical device or IVD manufacturing industry.
- Education: Bachelor’s degree in Life Sciences or a related field.
- Skills:
- Strong communication and interpersonal abilities.
- Excellent organizational and problem-solving skills.
- Ability to work independently and collaboratively within a team.
- Preferred Background: Prior experience in the healthcare or diagnostic industry.
Why Join Us?
- Be a part of an industry-leading team driving innovation in healthcare diagnostics.
- Contribute to high-impact projects with global regulatory significance.
- Work in a supportive and collaborative environment that fosters professional growth.
How to Apply
If you meet the qualifications and are excited about this opportunity, send your CV to admin-hr@genuinebiosystem.com. Make your mark in the thriving field of in-vitro diagnostics and regulatory affairs.
