Quality Assurance & Regulatory Affairs Role at B Braun – Apply Now! 

Quality Assurance & Regulatory Affairs Role at B Braun- Apply Now! 

Oyster Medisafe Pvt. Ltd. is a reputable pharmaceutical company dedicated to ensuring the well-being of patients by providing high-quality medical products. With a focus on innovation, quality, and compliance, we strive to make a positive impact on healthcare.

Job Posting Details:

• Job Title: Executive – Quality Assurance & Regulatory Affairs
• Location: Hyderabad, India
• Functional Area: Regulatory Affairs
• Working Model: Onsite
• Requisition ID: 1278

Job Summary:

We seek a highly skilled and experienced Executive for our Quality assurance & Regulatory Affairs team. The ideal candidate will be responsible for document management (Digitally), ensuring compliance with regulatory requirements. This role involves managing documentation, handling quality systems, and liaising with local and central drug authorities in India to ensure our products meet all necessary regulations.

Key Responsibilities:

• Regulatory Compliance: Ensure compliance with ISO 13485, CE marking, and other relevant regulatory standards.
• Documentation Management: Act as the document controller, maintaining and managing all quality and regulatory documentation in the digital documentation system.
• Quality Systems: Oversee the implementation and maintenance of GMP and quality management systems.
• Liaison with Authorities: Communicate with drug authorities and other regulatory bodies to ensure product compliance. Also, liaise with regulatory authorities to obtain various certificates and licenses.
• Audits and Inspections: Prepare for and support internal and external audits and inspections.
• Training and Development: Provide training to staff on quality and regulatory requirements and best practices.
• Continuous Improvement: Identify areas for improvement in quality and regulatory processes and implement necessary changes.
• Artwork Management: Responsible for creating/updating printing artworks in compliance with various regulatory requirements by liaising with internal/external service providers.

Job Requirements:

• Education: Bachelor’s degree in a relevant field (e.g., BioEngineering, Life Sciences, Engineering, Quality Management).
• Experience: Minimum of 3-5 years of experience in quality and regulatory affairs, preferably in the medical device or pharmaceutical industry.
• Certifications: Preferable to have internal auditor certification in ISO 13485 & awareness of Indian Medical Device Rule and EU Medical Device Regulations.
• Knowledge: Strong understanding of regulatory requirements and standards, including ISO 13485, CE marking, EU MDR 2017/745, and Indian Medical Device Rules & regulations.
• Skills: Excellent document management and system handling skills. Strong communication and interpersonal skills.
• Attention to Detail: High accuracy and attention to detail in all tasks.

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Keywords: Executive, Quality Assurance, Regulatory Affairs, Oyster Medisafe Pvt. Ltd., Hyderabad, Regulatory Compliance, Documentation Management, Quality Systems, Audits, Inspections, Training, Development, Medical Device, Pharmaceutical Industry