Oyster Medisafe Pvt. Ltd., a subsidiary of B. Braun, is seeking a highly skilled and experienced Executive – Quality Assurance & Regulatory Affairs to join their team in Hyderabad, India.
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Executive – Quality Assurance & Regulatory Affairs
Company: Oyster Medisafe Pvt. Ltd.
Job Posting Location: IN-Hyderabad
Functional Area: Regulatory Affairs
Working Model: Onsite
Requisition ID: 1278
Job Summary:
We are seeking a highly skilled and experienced Executive for our Quality & 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 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 authority to obtain various certificates and licences.
- 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 to create / update 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., Bio Engineering, 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: Preferrable to have internal auditor certification in ISO 13485 & awareness on 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 level of accuracy and attention to detail in all tasks.
