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Executive - Quality Assurance & Regulatory Affairs

2+ years
Not Disclosed
10 Dec. 19, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Executive - Quality Assurance & Regulatory Affairs
Company: Oyster Medisafe Pvt. Ltd. (B. Braun Group)
Location: Hyderabad, India
Functional Area: Regulatory Affairs
Working Model: Onsite
Requisition ID: 1278

Job Summary:
We are looking for a skilled and experienced Executive to join our Quality & Regulatory Affairs team. The ideal candidate will manage documentation, ensure compliance with regulatory standards, and oversee the implementation of quality systems. This role involves liaising with local and central drug authorities in India to ensure products meet all necessary regulatory requirements.

Key Responsibilities:

  • Regulatory Compliance: Ensure compliance with ISO 13485, CE marking, and other relevant regulatory standards.
  • Documentation Management: Serve as the document controller, maintaining all quality and regulatory documentation in the digital documentation system.
  • Quality Systems: Manage the implementation and maintenance of GMP and quality management systems.
  • Liaison with Authorities: Communicate with drug authorities and regulatory bodies to ensure product compliance. Obtain relevant certificates and licenses from regulatory authorities.
  • Audits and Inspections: Support and prepare for 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: Ensure compliance of printing artworks with various regulatory requirements by collaborating with internal and external service providers.

Job Requirements:

  • Education: Bachelor's degree in a relevant field (e.g., Bio Engineering, Life Sciences, Engineering, Quality Management).
  • Experience: 3-5 years of experience in quality and regulatory affairs, preferably in the medical device or pharmaceutical industry.
  • Certifications: Internal auditor certification in ISO 13485 and knowledge of Indian Medical Device Rules and EU Medical Device Regulations are preferred.
  • Knowledge: Strong understanding of regulatory standards, including ISO 13485, CE marking, EU MDR 2017/745, and Indian Medical Device Rules.
  • Skills: Excellent document management skills, strong communication, and interpersonal abilities.
  • Attention to Detail: High accuracy and attention to detail in all tasks.